Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections

NCT ID: NCT04900220

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2023-04-10

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.

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.

Conditions

Trigger Finger

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Betamethasone

betamethasone

Group Type: ACTIVE_COMPARATOR

Betamethasone

Intervention Type: DRUG

The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg)

Methylprednisolone

methylprednisolone

Group Type: ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type: DRUG

The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)

Interventions

Betamethasone

The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg)

Intervention Type: 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)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Shafic Sraj, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shatic Sraj, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

WVU Medicine University Town Center

Morgantown, West Virginia, United States

Ruby Memorial Hospital or Other WVU Healthcare Site

Morgantown, West Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2103263450

Identifier Type: -

Identifier Source: org_study_id