A Phase 4 interventional study of Betamethasone and Methylprednisolone in Trigger Finger, sponsored by West Virginia University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-23.
Sponsored by West Virginia University · Phase 4, Interventional, and Treatment
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.
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.
93 studies on the registry are indexed under Trigger Finger Disorder; 22 are open to participants now.
This study's enrollment of 66 is close to the median of 66 across 75 interventional studies indexed under Trigger Finger Disorder.
Browse Trigger Finger Disorder studies →West Virginia University is the lead sponsor of 157 studies on the registry; 36 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
betamethasone
Drug: Betamethasone
methylprednisolone
Drug: Methylprednisolone
The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg)
The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
Incidence of Pain
Recorded when subject reports pain. Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Time frame: Up to 7 days
Intensity of Pain
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Time frame: Up to 7 days
Incidence of Flare Reaction
Number of patients having a severe flare reaction
Time frame: From baseline up to 7 days
Patients seen in the Hand Clinic for single trigger finger issues were approached for the project.
| Milestone | Betamethasone | Methylprednisolone |
|---|---|---|
| Started | 33 | 33 |
| Completed | 32 | 32 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
Recorded when subject reports pain. Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
| Participants | Betamethasone | Methylprednisolone |
|---|---|---|
| Incidence of Pain | 6 | 11 |
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
| score on a scale | Betamethasone | Methylprednisolone |
|---|---|---|
| Baseline | 2.8 (0 to 10) | 2.1 (0 to 10) |
| Five Minutes | 0.3 (0 to 10) | 0.8 (0 to 10) |
| Day 1 | 1.4 (0 to 10) | 2.9 (0 to 10) |
| Day 2 | 1.3 (0 to 10) | 2.1 (0 to 10) |
| Day 3 | 1.0 (0 to 10) | 1.5 (0 to 10) |
| Day 4 | 0.7 (0 to 10) | 1.0 (0 to 10) |
| Day 5 | 0.6 (0 to 10) | 0.8 (0 to 10) |
| Day 6 | 0.6 (0 to 10) | 0.7 (0 to 10) |
| Day 7 | 0.5 (0 to 10) | 0.6 (0 to 10) |
Number of patients having a severe flare reaction
| Participants | Betamethasone | Methylprednisolone |
|---|---|---|
| Severe Flare | 2 | 5 |
| No Severe Flare | 30 | 27 |
Collected over Adverse events were reviewed over a 7 day period, from time of injection until flare resolution.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Betamethasone | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Methylprednisolone | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Age, Continuous(years) | Betamethasone | Methylprednisolone | Total |
|---|---|---|---|
| Mean | 63.4 ± 12.7 | 58.5 ± 12.6 | 60.9 ± 12.8 |
| Sex: Female, Male(Participants) | Betamethasone | Methylprednisolone | Total |
|---|---|---|---|
| Female | 18 | 23 | 41 |
| Male | 14 | 9 | 23 |
| Race and Ethnicity Not Collected(Participants) | Betamethasone | Methylprednisolone | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Betamethasone | Methylprednisolone | Total |
|---|---|---|---|
| United States | 32 | 32 | 64 |
| Tobacco Use(Participants) | Betamethasone | Methylprednisolone | Total |
|---|---|---|---|
| Smokers | 4 | 2 | 6 |
| Non-Smokers | 28 | 30 | 58 |
| Hand Dominance(Participants) | Betamethasone | Methylprednisolone | Total |
|---|---|---|---|
| Right | 29 | 27 | 56 |
| Left | 3 | 5 | 8 |
| Side of Trigger(Participants) | Betamethasone | Methylprednisolone | Total |
|---|---|---|---|
| Right | 20 | 20 | 40 |
| Left | 12 | 12 | 24 |
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Betamethasone · Methylprednisolone