Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis
Sponsor
University of Oslo (Other)
Overall Status
Completed
CT.gov ID
NCT00826462
Collaborator
Allmennmedisinsk forskningsfond, Norway (Other)
177
1
3
51
3.5
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the clinical effect of physiotherapy alone or combined with corticosteroid injection in the initial treatment of lateral epicondylitis in a primary care setting.
To find the short and long term effect of physiotherapy with Mill's manipulation, deep friction massage and exercise therapy.
To ascertain wether the outcome is influenced by corticosteroid injection, which has been shown to be of benefit alone in the short term?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Much has been written about lateral epicondylitis/tennis elbow reflecting the existence of many treatments for the condition. However, there is no consensus as to which treatment gives the best results.
Based on the latest meta-studies and reviews from the Cochrane Library, one may conclude that there is evidence of a short-term effect of topical or per oral NSAIDs. The same is true for manipulation and exercise. Corticosteroid injection has also been shown to have short-term effect, but not beyond 6 weeks. Ultrasound has a possible short-term effect based on one meta-analysis. Extra corporeal shock wave therapy does not seem to be effective. The treatment with acupuncture, orthosis, surgery or long-term NSAIDs has no support in the literature, and it is impossible to draw any conclusions about the effects or absence thereof. In fact, there is scant support for any long-term treatment in the literature.
We have found two studies to be of special interest (see citations below). Both have been done in a primary care setting with one-year follow up. One study compares corticosteroid injection with physical therapy (ultrasound, manipulation and exercise) and a wait-and-see group. The other compares corticosteroid injection with naproxen orally and placebo-medication. Both conclude that corticosteroid injection is a safe and effective treatment as pain-relief during the first 6 weeks, and that the effect of this treatment is better than physical therapy, wait-and-see and naproxen orally within the same time-frame. Physical therapy in one study gives some, but not statistically significantly better long-term (one year) effect than wait-and-see treatment.
There seems to be some indication that corticosteroid injection is a good alternative for the first 6 weeks. We find there is a good reason to investigate the long-term effects of physical therapy. At the same time, it would be interesting to see whether the good initial response from corticosteroid injection may be extended if combined with physiotherapy.
This randomised, placebo-controlled study will be conducted in general practice in the town of Sarpsborg, Ostfold County, Norway including patient aged 18-70 years with pain of recent onset from the lateral part of the elbow. After a treatment-period of 6 weeks, the patient is followed for a total of 12 months.
Patients are recruited by interested general practitioners in the city of Sarpsborg and surroundings and remitted to two study-physicians who make the initial evaluation of inclusion- and exclusion criteria, as well as treatment, follow-up and outcome assessments during the whole study-period. The patients are treated by one of the two study-physicians in the 6-weeks treatment-period. From the 6. week, the patient sees the other physician, who is unaware of the allocated intervention, for further registration and assessment.
Study Design
Study Type:
Interventional
Actual Enrollment
:
177 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Physiotherapy Alone, in Combination With Corticosteroid Injection or Wait-and-see for Acute Lateral Epicondylitis in General Practice: a Randomised, Placebo-controlled Study With 12 Months Follow-up
Study Start Date
:
Mar 1, 2009
Actual Primary Completion Date
:
Jun 1, 2013
Actual Study Completion Date
:
Jun 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days |
Drug: triamcinolone
Injection with triamcinolone 10 mg at start and at 3 weeks
Other Names:
Drug: Lidocaine
10 mg of lidocaine at start and at 3 weeks
Other Names:
Other: Physiotherapy
12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises
Other Names:
Drug: Naproxen
Naproxen 500 mg bid for 14 days
Other Names:
|
| Placebo Comparator: 2 Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days |
Drug: Placebo
Injection with sodium chloride at start and at 3 weeks
Other Names:
Drug: Lidocaine
10 mg of lidocaine at start and at 3 weeks
Other Names:
Other: Physiotherapy
12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises
Other Names:
Drug: Naproxen
Naproxen 500 mg bid for 14 days
Other Names:
|
| Active Comparator: 3 Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days |
Drug: Naproxen
Naproxen 500 mg bid for 14 days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Treatment Success - Event Rates in Each Group [6 - 52 weeks]
Unadjusted event rates of treatment success, defined as participants rating themselves 'much improved' or 'completely recovered' on a six point scale. Percentage with 99% confidence interval.
Secondary Outcome Measures
- Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale) [6 weeks]
Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome.
- Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale). [12 weeks]
Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome.
- Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale). [26 weeks]
Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome.
- Pain as Recorded by the Study Doctors on a 100 mm VAS-scale [52 weeks]
Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome.
- Pain-free Grip Strength Ratio [6 weeks]
Pain free grip strength registered with hand held dynamometer . Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint.
- Pain-free Grip Strength Ratio [12 weeks]
Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint.
- Pain-free Grip Strength Ratio [26 weeks]
Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint.
- Pain-free Grip Strength Ratio [52 weeks]
Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint.
- Maximum Grip Strength Ratio [6 weeks]
Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain.
- Maximum Grip Strength Ratio [12 weeks]
Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain.
- Maximum Grip Strength Ratio [26 weeks]
Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain.
- Maximum Grip Strength Ratio [52 weeks]
Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain.
- Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors [6 weeks]
To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome.
- Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors [12 weeks]
To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome.
- Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors [26 weeks]
To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome.
- Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors [52 weeks]
To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome.
- Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors [6 weeks]
Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome.
- Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors [12 weeks]
Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome.
- Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors [26 weeks]
Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome.
- Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors [52 weeks]
Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome.
- Pain Free Function Index of Everyday Activities [6 weeks]
Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment.
- Pain Free Function Index of Everyday Activities [12 weeks]
Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment.
- Pain Free Function Index of Everyday Activities [26 weeks]
Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment.
- Pain Free Function Index of Everyday Activities [52 weeks]
Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment.
- No Pain on Three Point Likert Scale on Dorsiflexion of Wrist [6 weeks]
Percentage of patients reporting "no pain" on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
- No Pain on Three Point Likert Scale on Dorsiflexion of Wrist [12 weeks]
Percentage of patients reporting "no pain" on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
- No Pain on Three Point Likert Scale on Dorsiflexion of Wrist [26 weeks]
Percentage of patients reporting "no pain" on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
- No Pain on Three Point Likert Scale on Dorsiflexion of Wrist [52 weeks]
Percentage of patients reporting "no pain" on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
- No Pain on Three Point Likert Scale on Isometric Extension of Third Finger [6 weeks]
Percentage of patients reporting "no pain" on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
- No Pain on Three Point Likert Scale on Isometric Extension of Third Finger [12 weeks]
Percentage of patients reporting "no pain" on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
- No Pain on Three Point Likert Scale on Isometric Extension of Third Finger [26 weeks]
Percentage of patients reporting "no pain" on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
- No Pain on Three Point Likert Scale on Isometric Extension of Third Finger [52 weeks]
Percentage of patients reporting "no pain" on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age 18-70 years
-
Pain from the lateral part of the elbow
-
The pain increases on resisted dorsiflexion of the wrist with the elbow extended and the fingers flexed or the pain increases on resisted radial deviation of the wrist or the pain increases on resisted extension of the 3. finger
Exclusion Criteria:
-
Duration of complaints less than 2 weeks or more than 3 months
-
The tenderness is located within the muscle body itself in the proximal part of the short radial extensors muscle of the wrist (Cyriax type IV)9.
-
Treatment within the last 12 months for the same condition with corticosteroid injection or physiotherapy
-
Bilateral complaints
-
Previous surgical treatment for lateral epicondylitis
-
Deformities of the elbow (congenital or acquired)
-
Cervical radiculopathy or referred pain from neck or shoulder
-
Previous fractures or tendon ruptures in the elbow
-
Systemic musculoskeletal disease
-
Previous allergic reactions to corticosteroids or lidocaine
-
Contraindications to corticosteroids or NSAIDs:
-
On-going or previous gastro-intestinal bleeding
-
previous ulcer or dyspepsia, severe asthma
-
on-going systemic infection
-
local skin-infection
-
recently vaccinated with live virus
-
coagulopathies
-
systemic lupus erythematodes
-
severe liver- or kidney-disease
-
heart failure
-
diabetes
-
use of warfarin or NSAIDS
-
Pregnancy or breast-feeding
-
Fertile females not on effective birth control
-
Psycho-social or other reasons for not being able to participate throughout the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Grålum legesenter | Sarpsborg | Norway | 1712 |
Sponsors and Collaborators
- University of Oslo
- Allmennmedisinsk forskningsfond, Norway
Investigators
- Study Chair: Morten Lindbaek, Ph. D., University of Oslo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Morten Lindbaek,
Professor Dr.med,
University of Oslo
ClinicalTrials.gov Identifier:
NCT00826462
Other Study ID Numbers:
- 2006-002283-26
First Posted:
Jan 22, 2009
Last Update Posted:
Jan 24, 2022
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Morten Lindbaek,
Professor Dr.med,
University of Oslo
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Period Title: Overall Study | |||
| STARTED | 59 | 58 | 60 |
| COMPLETED | 52 | 53 | 52 |
| NOT COMPLETED | 7 | 5 | 8 |
Baseline Characteristics
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment | Total |
|---|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days | Total of all reporting groups |
| Overall Participants | 59 | 58 | 60 | 177 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
47.9
(9.6)
|
48.8
(9.4)
|
44.0
(9.7)
|
46.9
(9.7)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
26
44.1%
|
20
34.5%
|
25
41.7%
|
71
40.1%
|
| Male |
33
55.9%
|
38
65.5%
|
35
58.3%
|
106
59.9%
|
| Region of Enrollment (participants) [Number] | ||||
| Norway |
59
100%
|
58
100%
|
60
100%
|
177
100%
|
Outcome Measures
| Title | Treatment Success - Event Rates in Each Group |
|---|---|
| Description | Unadjusted event rates of treatment success, defined as participants rating themselves 'much improved' or 'completely recovered' on a six point scale. Percentage with 99% confidence interval. |
| Time Frame | 6 - 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Control Group: Wait-and-see Treatment | Placebo Injection in Combination With Physical Therapy | Corticosteroid Injection in Combination With Physical Therapy |
|---|---|---|---|
| Arm/Group Description | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 60 | 58 | 59 |
| 6 weeks |
15
25.4%
|
24
41.4%
|
59
98.3%
|
| 12 weeks |
48
81.4%
|
45
77.6%
|
42
70%
|
| 26 weeks |
67
113.6%
|
69
119%
|
42
70%
|
| 52 weeks |
78
132.2%
|
78
134.5%
|
75
125%
|
| Title | Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale) |
|---|---|
| Description | Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [mm] |
29
(25)
|
45
(23)
|
44
(25)
|
| Title | Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale). |
|---|---|
| Description | Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [mm] |
41
(26)
|
33
(26)
|
33
(26)
|
| Title | Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale). |
|---|---|
| Description | Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. |
| Time Frame | 26 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [mm] |
38
(28)
|
21
(22)
|
19
(22)
|
| Title | Pain as Recorded by the Study Doctors on a 100 mm VAS-scale |
|---|---|
| Description | Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [mm] |
19
(23)
|
9
(11)
|
13
(19)
|
| Title | Pain-free Grip Strength Ratio |
|---|---|
| Description | Pain free grip strength registered with hand held dynamometer . Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [Ratio x 100] |
58
(35)
|
50
(29)
|
57
(32)
|
| Title | Pain-free Grip Strength Ratio |
|---|---|
| Description | Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [Ratio x 100] |
64
(43)
|
55
(25)
|
63
(36)
|
| Title | Pain-free Grip Strength Ratio |
|---|---|
| Description | Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. |
| Time Frame | 26 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [Ratio x 100] |
82
(48)
|
76
(27)
|
74
(37)
|
| Title | Pain-free Grip Strength Ratio |
|---|---|
| Description | Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [Ratio x 100] |
100
(33)
|
90
(23)
|
91
(23)
|
| Title | Maximum Grip Strength Ratio |
|---|---|
| Description | Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [Ratio x 100] |
87
(26)
|
80
(25)
|
74
(27)
|
| Title | Maximum Grip Strength Ratio |
|---|---|
| Description | Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [Ratio x 100] |
83
(29)
|
88
(23)
|
89
(28)
|
| Title | Maximum Grip Strength Ratio |
|---|---|
| Description | Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. |
| Time Frame | 26 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [Ratio x 100] |
89
(27)
|
99
(20)
|
99
(19)
|
| Title | Maximum Grip Strength Ratio |
|---|---|
| Description | Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [Ratio x 100] |
96
(19)
|
102
(17)
|
104
(15)
|
| Title | Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors |
|---|---|
| Description | To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [mm] |
25
(23)
|
45
(24)
|
38
(26)
|
| Title | Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors |
|---|---|
| Description | To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [mm] |
37
(29)
|
32
(25)
|
34
(28)
|
| Title | Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors |
|---|---|
| Description | To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. |
| Time Frame | 26 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [mm] |
28
(25)
|
17
(22)
|
16
(20)
|
| Title | Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors |
|---|---|
| Description | To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [mm] |
16
(22)
|
9
(15)
|
10
(17)
|
| Title | Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors |
|---|---|
| Description | Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [mm] |
32
(26)
|
50
(26)
|
51
(28)
|
| Title | Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors |
|---|---|
| Description | Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [mm] |
43
(30)
|
35
(28)
|
36
(27)
|
| Title | Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors |
|---|---|
| Description | Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. |
| Time Frame | 26 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [mm] |
36
(26)
|
19
(23)
|
18
(20)
|
| Title | Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors |
|---|---|
| Description | Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [mm] |
20
(24)
|
9
(13)
|
12
(19)
|
| Title | Pain Free Function Index of Everyday Activities |
|---|---|
| Description | Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [score on a scale] |
2.78
(2.22)
|
4.40
(2.01)
|
4.82
(2.16)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Control Group: Wait-and-see Treatment, Placebo Injection in Combination With Physical Therapy, Corticosteroid Injection in Combination With Physical Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | linear generalized estimating equations | |
| Comments | ||
| Other Statistical Analysis | A linear GEE regression model adjusted for the significant covariates at p < 0.05 from the univariate GEE logistic regression models calculated for success | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Control Group: Wait-and-see Treatment, Placebo Injection in Combination With Physical Therapy, Corticosteroid Injection in Combination With Physical Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | linear generalized estimating equations | |
| Comments | ||
| Title | Pain Free Function Index of Everyday Activities |
|---|---|
| Description | Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [score on a scale] |
3.42
(2.63)
|
3.62
(2.43)
|
3.37
(2.36)
|
| Title | Pain Free Function Index of Everyday Activities |
|---|---|
| Description | Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. |
| Time Frame | 26 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [score on a scale] |
2.97
(2.53)
|
1.83
(2.08)
|
2.00
(2.25)
|
| Title | Pain Free Function Index of Everyday Activities |
|---|---|
| Description | Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Mean (Standard Deviation) [score on a scale] |
1.64
(2.04)
|
1.03
(1.67)
|
1.40
(1.90)
|
| Title | No Pain on Three Point Likert Scale on Dorsiflexion of Wrist |
|---|---|
| Description | Percentage of patients reporting "no pain" on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Number (99% Confidence Interval) [percentage of participants] |
36
61%
|
3
5.2%
|
8
13.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Control Group: Wait-and-see Treatment, Placebo Injection in Combination With Physical Therapy, Corticosteroid Injection in Combination With Physical Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Other Statistical Analysis | linear generalized estimating equations (GEE) regression model adjusted for significant covariates; between groups estimated odds ratio (OR) for no pain on two isometric movements using logistic GEE regression model adjusted for significant covariates; 99 % confidence intervals | |
| Title | No Pain on Three Point Likert Scale on Dorsiflexion of Wrist |
|---|---|
| Description | Percentage of patients reporting "no pain" on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Number (99% Confidence Interval) [percentage of patients] |
22
|
12
|
17
|
| Title | No Pain on Three Point Likert Scale on Dorsiflexion of Wrist |
|---|---|
| Description | Percentage of patients reporting "no pain" on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain. |
| Time Frame | 26 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Number (99% Confidence Interval) [percentage of patients] |
19
|
29
|
38
|
| Title | No Pain on Three Point Likert Scale on Dorsiflexion of Wrist |
|---|---|
| Description | Percentage of patients reporting "no pain" on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Number (99% Confidence Interval) [percentage of patients] |
36
|
60
|
50
|
| Title | No Pain on Three Point Likert Scale on Isometric Extension of Third Finger |
|---|---|
| Description | Percentage of patients reporting "no pain" on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Number (99% Confidence Interval) [percentage of patients] |
44
|
16
|
17
|
| Title | No Pain on Three Point Likert Scale on Isometric Extension of Third Finger |
|---|---|
| Description | Percentage of patients reporting "no pain" on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Number (99% Confidence Interval) [percentage of patients] |
36
|
24
|
22
|
| Title | No Pain on Three Point Likert Scale on Isometric Extension of Third Finger |
|---|---|
| Description | Percentage of patients reporting "no pain" on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain. |
| Time Frame | 26 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Number (99% Confidence Interval) [percentage of patients] |
31
|
53
|
58
|
| Title | No Pain on Three Point Likert Scale on Isometric Extension of Third Finger |
|---|---|
| Description | Percentage of patients reporting "no pain" on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Our study was performed on an intention to treat basis. The number of participants in each included arm therefore was subsequently kept as the denominator at each follow - up regardless of any drop outs. |
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment |
|---|---|---|---|
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days |
| Measure Participants | 59 | 58 | 60 |
| Number (99% Confidence Interval) [percentage of patients] |
53
|
76
|
63
|
Adverse Events
| Time Frame | 1 year | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment | |||
| Arm/Group Description | Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days triamcinolone: Injection with triamcinolone 10 mg at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days Placebo: Injection with sodium chloride at start and at 3 weeks Lidocaine: 10 mg of lidocaine at start and at 3 weeks Physiotherapy: 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises Naproxen: Naproxen 500 mg bid for 14 days | Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days Naproxen: Naproxen 500 mg bid for 14 days | |||
All Cause Mortality |
||||||
| Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/59 (0%) | 0/58 (0%) | 0/60 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Corticosteroid Injection in Combination With Physical Therapy | Placebo Injection in Combination With Physical Therapy | Control Group: Wait-and-see Treatment | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/59 (10.2%) | 5/58 (8.6%) | 10/60 (16.7%) | |||
| Gastrointestinal disorders | ||||||
| GI side effects | 6/59 (10.2%) | 3/58 (5.2%) | 8/60 (13.3%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Increased pain | 0/59 (0%) | 2/58 (3.4%) | 2/60 (3.3%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Skin atrophy | 0/59 (0%) | 0/58 (0%) | 0/60 (0%) | |||
Limitations/Caveats
Strict inclusion criteria limit generalizability.The patients were not blinded to physiotherapy.Home exercises not logged.Only one physiotherapist.No individual adjustment of treatment. .We did not look specifically at recurrence rates.
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Professor Morten Lindbaek |
|---|---|
| Organization | University of Oslo |
| Phone | +47-22850646 |
| morten.lindbak@medisin.uio.no |
Responsible Party:
Morten Lindbaek,
Professor Dr.med,
University of Oslo
ClinicalTrials.gov Identifier:
NCT00826462
Other Study ID Numbers:
- 2006-002283-26
First Posted:
Jan 22, 2009
Last Update Posted:
Jan 24, 2022
Last Verified:
Nov 1, 2021