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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Betamethasone | Active Comparator | betamethasone |
|
| Methylprednisolone | Active Comparator | methylprednisolone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betamethasone | Drug | The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Up to 7 days |
| Incidence of Flare Reaction | Number of patients having a severe flare reaction | From baseline up to 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shatic Sraj, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WVU Medicine University Town Center | Morgantown | West Virginia | 26501 | United States | ||
| Ruby Memorial Hospital or Other WVU Healthcare Site |
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Patients seen in the Hand Clinic for single trigger finger issues were approached for the project.
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| ID | Title | Description |
|---|---|---|
| FG000 | Betamethasone | betamethasone Betamethasone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg) |
| FG001 | Methylprednisolone | methylprednisolone Methylprednisolone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Betamethasone | betamethasone Betamethasone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg) |
| BG001 | Methylprednisolone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Up to 7 days |
|
Adverse events were reviewed over a 7 day period, from time of injection until flare resolution.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Betamethasone | betamethasone Betamethasone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shafic Sraj - Associate Professor | West Virginia University | 304-293-3007 | shafic.sraj@hsc.wvu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 22, 2021 | May 26, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2022 | May 26, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D052582 | Trigger Finger Disorder |
| ID | Term |
|---|---|
| D053682 | Tendon Entrapment |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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This is a double-blinded randomized trial enrolling patients into one of the two treatment groups. The volume of the doses of steroid to be given will be standardized to 1 cc of either methylprednisolone (40 mg) or betamethasone (6 mg). We will instruct patients who meet the inclusion criteria to complete a visual analog scale (VAS) of their pain (1-10) prior to the injection, immediately after the injection, five minutes after the injection, and once a day for a minimum of 7 days after the injection. 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.
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| Methylprednisolone | Drug | The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg) |
|
| Morgantown |
| West Virginia |
| 26506 |
| United States |
methylprednisolone
Methylprednisolone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Tobacco Use | Count of Participants | Participants |
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| Hand Dominance | Count of Participants | Participants |
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| Side of Trigger | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Intensity of Pain | Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever | Posted | Mean | Full Range | score on a scale | Up to 7 days |
|
|
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| Primary | Incidence of Flare Reaction | Number of patients having a severe flare reaction | Posted | Count of Participants | Participants | From baseline up to 7 days |
|
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|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Methylprednisolone | methylprednisolone Methylprednisolone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg) | 0 | 32 | 0 | 32 | 0 | 32 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011239 | Prednisolone |
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