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Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections

Primary Purpose

Trigger Finger

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Betamethasone
Methylprednisolone
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Finger

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • WVU Medicine University Town Center
  • Ruby Memorial Hospital or Other WVU Healthcare Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Betamethasone

Methylprednisolone

Arm Description

betamethasone

methylprednisolone

Outcomes

Primary Outcome Measures

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
Intensity of Pain
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Incidence of Flare Reaction
Number of patients having a severe flare reaction

Secondary Outcome Measures

Full Information

First Posted
May 20, 2021
Last Updated
May 30, 2023
Sponsor
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT04900220
Brief Title
Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections
Official Title
Investigating Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections Using Betamethasone and Methylprednisolone
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
December 27, 2022 (Actual)
Study Completion Date
April 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Betamethasone
Arm Type
Active Comparator
Arm Description
betamethasone
Arm Title
Methylprednisolone
Arm Type
Active Comparator
Arm Description
methylprednisolone
Intervention Type
Drug
Intervention Name(s)
Betamethasone
Intervention Description
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
Intervention Name(s)
Methylprednisolone
Intervention Description
The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
Primary Outcome Measure Information:
Title
Incidence of Pain
Description
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
Title
Intensity of Pain
Description
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Time Frame
Up to 7 days
Title
Incidence of Flare Reaction
Description
Number of patients having a severe flare reaction
Time Frame
From baseline up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shatic Sraj, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
WVU Medicine University Town Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26501
Country
United States
Facility Name
Ruby Memorial Hospital or Other WVU Healthcare Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

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Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections

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