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Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting

Primary Purpose

Trigger Finger, Stenosing Tenosynovitis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Corticosteroid injection + Trigger Splint+ Education and Home exercises
Corticosteroid injection
Sponsored by
The Philadelphia & South Jersey Hand Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Finger focused on measuring trigger finger, orthotic intervention

Eligibility Criteria

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

Inclusion Criteria:

  • Trigger finger in one or more trigger fingers, in stages 2 to 5 (inclusive)
  • Adult patient aged over 18 years.
  • No prior treatment (splinting, injection or surgery) to the involved finger OR at least 1 year since last treatment of the involved finger.

Exclusion Criteria:

  • Exclude Trigger thumbs because they appear to be respond very favorably or unfavorably to treatment3
  • Exclude locked digits because surgery is indicated in these cases
  • Pregnant patients
  • Prisoners
  • Patients with impaired decision-making capacity
  • Patients that do not speak English and cannot fill in English language questionnaires.

Sites / Locations

  • The Philadelphia and South Jersey Hand Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Corticosteroid injection

Corticosteroid Injection and Trigger Splint

Arm Description

Standard corticosteroid injection.

Corticosteroid Injection + Trigger Splint + Education + Home Exercises

Outcomes

Primary Outcome Measures

Stage of finger triggering
Trigger Finger Stage: Normal Painful palpable nodule Triggering = Clicking = Catching Locking of finger in flexion or extension unlocked by active finger movement Locking of finger in flexion or extension unlocked by passive finger movement Locked finger in flexion or extension (Each stage may be painless or painful)

Secondary Outcome Measures

Failed treatment: surgical intervention required
Failed treatment OR Successful treatment
Patient rated functional outcome
Quick Disabilities of the Arm, Shoulder and Hand questionnaire Patient Specific Functional Scale
Pain
Visual Analog Scale

Full Information

First Posted
June 21, 2013
Last Updated
March 17, 2015
Sponsor
The Philadelphia & South Jersey Hand Center
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1. Study Identification

Unique Protocol Identification Number
NCT01886157
Brief Title
Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting
Official Title
Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Philadelphia & South Jersey Hand Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypothesis: Treatment of trigger finger by corticosteroid injection and splinting is superior to corticosteroid treatment alone.
Detailed Description
Stenosing tenosynovitis, or more commonly "trigger finger" is a disease that can severely impact a patient's quality of life. Its incidence is said to be 28 persons per 100,000 annually. The disease is manifested in one or more fingers by finger locking in flexion or extension, leading to pain, discomfort and at times, loss of function. Patients frequently report having to snap their fingers back in position to alleviate symptoms. The pathophysiology relates to thickening of the flexor tendon sheath, which can impair tendon gliding within it. Although multiple treatment strategies are available, it is not entirely clear which treatment offers the best outcome, especially when the finger has not reached end stage locking. In general, corticosteroid injection into the tendon sheath is offered as the first line of treatment. Splinting alone has also been described as a reliable method treatment. However, Patel and Bassini indicated that steroid injection results in fewer recurrences than splinting alone. Surgery is typically reserved for recurrent triggering, cases refractory to injection, or digits locked in flexion. The effects of steroid injection followed by splinting however have not been reported in a comprehensive fashion. It may be that this form of treatment could result in a synergistic effect, which can offer a treatment modality superior to either injection or splinting alone. The purpose of this research study is to determine whether steroid injection followed by splinting is superior to injection alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger, Stenosing Tenosynovitis
Keywords
trigger finger, orthotic intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Corticosteroid injection
Arm Type
Active Comparator
Arm Description
Standard corticosteroid injection.
Arm Title
Corticosteroid Injection and Trigger Splint
Arm Type
Experimental
Arm Description
Corticosteroid Injection + Trigger Splint + Education + Home Exercises
Intervention Type
Procedure
Intervention Name(s)
Corticosteroid injection + Trigger Splint+ Education and Home exercises
Intervention Description
Standard corticosteroid injection. Hand based, single digit trigger splint will be applied. Education and instructions about home exercises.
Intervention Type
Procedure
Intervention Name(s)
Corticosteroid injection
Intervention Description
Standard trigger finger corticosteroid injection.
Primary Outcome Measure Information:
Title
Stage of finger triggering
Description
Trigger Finger Stage: Normal Painful palpable nodule Triggering = Clicking = Catching Locking of finger in flexion or extension unlocked by active finger movement Locking of finger in flexion or extension unlocked by passive finger movement Locked finger in flexion or extension (Each stage may be painless or painful)
Time Frame
1, 2, 4-6, and 12 months
Secondary Outcome Measure Information:
Title
Failed treatment: surgical intervention required
Description
Failed treatment OR Successful treatment
Time Frame
1,2, 4-6, 12months
Title
Patient rated functional outcome
Description
Quick Disabilities of the Arm, Shoulder and Hand questionnaire Patient Specific Functional Scale
Time Frame
1, 2, 4-6, 12months
Title
Pain
Description
Visual Analog Scale
Time Frame
1, 2, 4-6, 12 months
Other Pre-specified Outcome Measures:
Title
Compliance with splint and hand exercises
Description
For patients who are assigned to injection and splint group, home exercise and splint compliance will be assessed by patients maintaining a case log.
Time Frame
1, 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Trigger finger in one or more trigger fingers, in stages 2 to 5 (inclusive) Adult patient aged over 18 years. No prior treatment (splinting, injection or surgery) to the involved finger OR at least 1 year since last treatment of the involved finger. Exclusion Criteria: Exclude Trigger thumbs because they appear to be respond very favorably or unfavorably to treatment3 Exclude locked digits because surgery is indicated in these cases Pregnant patients Prisoners Patients with impaired decision-making capacity Patients that do not speak English and cannot fill in English language questionnaires.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidney Jacoby, MD
Organizational Affiliation
The Philadelphia and South Jersey Hand Center
Official's Role
Study Director
Facility Information:
Facility Name
The Philadelphia and South Jersey Hand Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18406955
Citation
Ring D, Lozano-Calderon S, Shin R, Bastian P, Mudgal C, Jupiter J. A prospective randomized controlled trial of injection of dexamethasone versus triamcinolone for idiopathic trigger finger. J Hand Surg Am. 2008 Apr;33(4):516-22; discussion 523-4. doi: 10.1016/j.jhsa.2008.01.001.
Results Reference
background
PubMed Identifier
269967
Citation
Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. No abstract available.
Results Reference
result
PubMed Identifier
19006759
Citation
Colbourn J, Heath N, Manary S, Pacifico D. Effectiveness of splinting for the treatment of trigger finger. J Hand Ther. 2008 Oct-Dec;21(4):336-43. doi: 10.1197/j.jht.2008.05.001. Epub 2008 Aug 22.
Results Reference
result
PubMed Identifier
1538090
Citation
Patel MR, Bassini L. Trigger fingers and thumb: when to splint, inject, or operate. J Hand Surg Am. 1992 Jan;17(1):110-3. doi: 10.1016/0363-5023(92)90124-8.
Results Reference
result

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Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting

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