Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections

NCT04900220 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2103263450
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Trigger Finger

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Betamethasone

ACTIVE COMPARATOR

betamethasone

Drug: Betamethasone

Methylprednisolone

ACTIVE COMPARATOR

methylprednisolone

Drug: Methylprednisolone

Interventions

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)

Betamethasone

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)

Methylprednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single trigger injection
• First time for the digit
• No prior surgery on digit

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (2)

WVU Medicine University Town Center

Morgantown, West Virginia, 26501, United States

Location

Ruby Memorial Hospital or Other WVU Healthcare Site

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Trigger Finger Disorder

Interventions

Betamethasone; Methylprednisolone

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Prednisolone

Results Point of Contact

• Title: Dr. Shafic Sraj - Associate Professor
• Organization: West Virginia University

shafic.sraj@hsc.wvu.edu

304-293-3007

Study Officials

• Shatic Sraj, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 25, 2021
• Study Start: September 15, 2021
• Primary Completion: December 27, 2022
• Study Completion: April 10, 2023
• Last Updated: June 23, 2023
• Results First Posted: June 23, 2023

Record last verified: 2023-05

Locations

US (2)