Local Injection Under US Control in GTPS.

Sponsor

Stephane Genevay (Other)

Overall Status

Terminated

CT.gov ID

NCT01807962

Collaborator

University Hospital, Geneva (Other)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We hypothesize that local ultrasound guided injection with corticosteroid and local anaesthetic are effective on the symptoms of GTPS.

Condition or Disease	Intervention/Treatment	Phase
Periarthritis Bursitis	Drug: rapidocain and bethametsaone Drug: sterile saline	Phase 3

Detailed Description

The greater trochanteric pain syndrome (GTPS) is a frequent soft tissue syndrome which is often not recognised by medical practitioners. Currently, there is no validated definition of this syndrome and it is classically defined as pain and tenderness in the region of the greater trochanter that may radiate down to the postero-lateral aspect of the thigh and may mimic nerve root compression.

The prevalence of GTPS amongst adult patients referred to a spine clinic for chronic low back pain (LBP) has been reported to be 20-35%. In addition to pain, GTPS induces functional disability which at times may profoundly interfere with patients' daily activities. The diagnosis of GTPS is suspected in a patient complaining of lateral hip pain. The reproduction of typical pain on palpation of the posterior part of the greater trochanter is the only well recognised clinical sign, although other clinical signs have been described. As is frequently the case with these type of syndromes, the physiopathology of GTPS is probably a mixture of several musculoskeletal problems, among which trochanteric bursitis and gluteus medius (GMe) tendinosis are the most frequently cited.

MRI studies have demonstrated GMe tendinosis or tears in patients with GTPS and MRI is used as the gold standard for the diagnosis of GTPS in many studies. Musculoskeletal ultrasound (US) is of increasing interest among rheumatologists. It readily demonstrates soft tissue lesions, fluid collections, allows dynamic examination and the undertaking of ultrasound guided procedures. GMe and gluteus minus (GMi) tendinopathy or tears as well as bursitis can be clearly demonstrated by ultrasound and US may guide steroid injection for the treatment of GMe tendinopathy. However, to date no study has compared the utility of MRI compared to US.

There are very few well-performed studies regarding the treatment of GTPS. Although poorly studied, analgesics and non steroidal anti-inflammatory drugs (NSAIDs) are often used as first line therapy. The duration of therapy required with these oral agents is unknown and there are significant potential side-effects from these treatments. The vast majority of patients referred to secondary or tertiary centres have failed these oral therapies. Some authors advocate physiotherapy (massage or stretching) but once again, there is no strong evidence to support this approach. Thus, most patients are treated with an injection of a combination of steroids and local anaesthetic. However, there is no convincing evidence in the literature that this practice is effective.

The use of musculoskeletal ultrasound (US) has been shown to improve the accuracy of corticosteroid injections for many joints and extra-articular structures such as bursa and tendon sheaths. Although small observational studies have suggested that local corticosteroid injection may be effective in the short term, no prospective controlled study has been carried out to establish the efficacy of this common intervention.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomised Double Blind Controlled Trial of Injection of Local Anaesthetic and Corticosteroid Under Ultrasound Control in the Greater Trochanteric Pain Syndrome.

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: rapidocain and bethametsaone Rapidocain and Bethametsaone : Lidocaine (Rapidocain(R)): 4ml of 1% Lidocaine Bethametasone (Diprophos): 1ml ampoule (containing 5mg/ml dipropionate de bétaméthasone and 2mg/ml phosphate disodique de bétaméthasone)	Drug: rapidocain and bethametsaone lidocaine (Rapidocain(R)): 4ml of 1% Lidocaine bethametasone (Diprophos): 1ml ampoule (containing 5mg/ml dipropionate de betamethasone and 2mg/ml phosphate disodique de betamethasone) Other Names: diprophos lidocaine
Placebo Comparator: sterile saline Placebo arm with 5ml of sterile saline (NaCl) solution	Drug: sterile saline Placebo = 5ml of sterile saline solution Other Names: NaCl

Arm

Intervention/Treatment

Active Comparator: rapidocain and bethametsaone

Rapidocain and Bethametsaone : Lidocaine (Rapidocain(R)): 4ml of 1% Lidocaine Bethametasone (Diprophos): 1ml ampoule (containing 5mg/ml dipropionate de bétaméthasone and 2mg/ml phosphate disodique de bétaméthasone)

Drug: rapidocain and bethametsaone

lidocaine (Rapidocain(R)): 4ml of 1% Lidocaine bethametasone (Diprophos): 1ml ampoule (containing 5mg/ml dipropionate de betamethasone and 2mg/ml phosphate disodique de betamethasone)

Other Names:

diprophos

lidocaine

Placebo Comparator: sterile saline

Placebo arm with 5ml of sterile saline (NaCl) solution

Drug: sterile saline

Placebo = 5ml of sterile saline solution

Other Names:

NaCl

Outcome Measures

Primary Outcome Measures

The efficacy of ultrasound-guided injection with corticosteroid and local anaesthetic for GTPS. [4 weeks]
Difference in pain intensity in the lateral hip region at 4 weeks between the 2 treatment groups, as measured by a NRS. Because the timing of the response to an infiltration is not well established we plan to examine pain both at 4 weeks, as well as longitudinally over 4 weeks(evolution of pain over time).

Secondary Outcome Measures

Number of "responders" [4 weeks]
Number of "responders" (defined as a reduction in NRS ≥ 1.5)at 4 weeks and at 6 months.
Number of patients with "low residual disease activity" [4 weeks]
Number of patients with "low residual disease activity" (defined as NRS ≤ 2.0)at 4 weeks and at 6 months.
PGI patient [4 weeks]
Patient Global Assessment
Lumbar spine function [4 weeks]
Lumbar spine function measured with the Oswestry questionnaire at 4 weeks and at 6 months
Hip joint function [4 weeks]
Hip joint function (Womac questionnaire)at 4 weeks and 6 months
QoL [4 weeks]
Quality of life (SF-12)at 4 weeks and 6 months
Requirement for oral analgesics [4 weeks]
Recording patient requirements for analgesics at weekly intervals following the intervention
Side effects of the intervention [4 weeks]
Clinical side effects - patients will be questioned specifically with respect to certain side-effects potentially linked to the injection technique and /or the injected substances. Any other side-effects cited by the patient will be recorded appropriately. Ultrasound-measured side-effects: hematoma, GMe or GMi tear, tendinosis or calcification post-intervention that had not been visualised on the initial US prior to the first injection. Measured at 4 weeks and at 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients complaining of lateral hip pain for more than 1 month.
NRS lateral hip pain score ≥ 4 in the preceding week.
Failure of another "standard" treatment:

Physiotherapy: local therapy or a stretching program, or
Analgesic treatment (minimum of 5 days of consecutive therapy, including, but not limited to, NSAIDs).

Typical lateral hip pain reproduced by palpation of the greater trochanter

Exclusion Criteria:

Age younger than 18 years old
Concomitant local surgical intervention for tumours, infection or fracture, based on clinical history and physical examination
Previous ipsilateral prosthetic hip surgery
Scheduled ipsilateral hip surgery within 3 months
Fibromyalgia (diagnosis established by a rheumatologist)
Flair of chronic inflammatory joint disease (as defined by a rheumatologist)
Skin lesions at the injection site
Allergy to one of the studied drugs
Anticoagulation with internal normalized ration (INR) >3
Blood coagulation disorder, such as haemophilia.
Serious and uncontrolled psychiatric disease (as assessed by the clinician as a contraindication for steroid)
Other contraindications to steroid use, such as:

uncontrolled diabetes (non-fasting blood glucose > 10 mmol/L)
unstable hypertension (systolic pressure > 160mmHg or diastolic pressure > 100mmHg), or
open or closed angle glaucoma.

Requirement for systemic steroids (including steroid injections) or dose modification of disease modifying anti-rheumatic drugs during the preceding three months. Oral corticosteroids (< 10mg / day of Prednisone or equivalent) will be permitted providing that the dose has been stable for 4 weeks prior to inclusion and that the patient is expected to remain on the baseline dose for the duration of the study.
Presence of a pacemaker or other metallic object that constitutes a CI to MRI, or severe claustrophobia
Pregnant women (according to a pregnancy test) or nursing (breastfeeding) mothers.
Unwillingness or inability to give informed consent.
Unavailability for follow-up