Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections
Study Details
Study Description
Brief Summary
Two common corticosteroids used for trigger finger treatment are betamethasone and methylprednisolone. Both injections are effective in treating trigger finger and the decision of which to use in treatment is currently a matter of the current practice and physician preference. The goal through this randomized trial is to see whether there is a difference between these two corticosteroids in inducing flare reactions and if there are any differences in the peak level of pain and their duration. Findings indicating a statistically significant difference in the incidence and/or intensity of the flare reactions would be clinically significant and would be evidence supporting the switch of current practice to one corticosteroid over the other.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
Corticosteroid injections are effective non-surgical approach to treating trigger finger (stenosing tenosynovitis) with success rates reported as high as 92% after just one injection [1]. Among their side effects is a post-injection flare of increased pain that is attributed to crystal-induced synovitis. Reports of these flares in the literature have been rare. Recent evidence their incidence can be as high as 33%. The investigators feel it is a more common clinical issue than traditionally reported and it would be beneficial to control and reduce their incidence if possible.
Two common corticosteroids used for trigger finger treatment are betamethasone and methylprednisolone. Both injections are effective in treating trigger finger and the decision of which to use in treatment is currently a matter of the current practice and physician preference. There is no literature comparing the side effects, specifically flare reactions between these two treatments. The goal through this randomized trial is to see whether there is a difference between these two corticosteroids in inducing flare reactions and if there are any differences in the peak level of pain and their duration.
This is a double-blinded randomized trial enrolling patients into one of the two treatment groups. The volume of the doses will be standardized to 1 cc of either methylprednisolone (40 mg) or betamethasone (6 mg). Patients, who meet the inclusion criteria, will be instructed to complete a visual analog scale (VAS) of their pain (1-10) prior to the injection, during the injection and once a day for the following 7 days after the injection. The investigators estimate that a minimum of 30 patients in each group will be needed to achieve a minimum of 80% power and 0.05 significance. The incidence, intensity, time to peak and time to resolution of the flare reactions (defined as a 2-point increase from pre-injection pain) will be assessed and compared between the two groups. Findings indicating a statistically significant difference in the incidence and/or intensity of the flare reactions would be clinically significant and would be evidence supporting the switch of current practice to one corticosteroid over the other.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Betamethasone betamethasone |
Drug: Betamethasone
The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg)
|
| Active Comparator: Methylprednisolone methylprednisolone |
Drug: Methylprednisolone
The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
|
Outcome Measures
Primary Outcome Measures
- Incidence of pain [Up to 7 days]
Recorded when subject reports pain. Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
- Intensity of pain [Up to 7 days]
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
- Peak of flare reaction [From baseline up to 7 days]
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever. Flare reactions are defined as a 2-point increase from pre-injection(baseline) pain.
- Resolution of flare reaction [Up to 7 days]
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever. Flare reactions are defined as a 2-point increase from pre-injection(baseline) pain.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Single trigger injection
-
First time for the digit
-
No prior surgery on digit
Exclusion Criteria:
-
Current oral steroid use
-
Rheumatoid arthritis
-
More than one single digit involved
-
Previous injection in same digit
-
Prior surgery on same digit
-
Other injections in the same clinic on the same day
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | WVU Medicine University Town Center | Morgantown | West Virginia | United States | 26501 |
| 2 | Ruby Memorial Hospital or Other WVU Healthcare Site | Morgantown | West Virginia | United States | 26506 |
Sponsors and Collaborators
- West Virginia University
Investigators
- Principal Investigator: Shatic Sraj, MD, West Virginia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2103263450