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

NCT ID: NCT01886157

Last Updated: 2015-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-05-31

Brief Summary

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Hypothesis: Treatment of trigger finger by corticosteroid injection and splinting is superior to corticosteroid treatment alone.

Detailed Description

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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.

Conditions

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Trigger Finger Stenosing Tenosynovitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Corticosteroid injection

Standard corticosteroid injection.

Group Type ACTIVE_COMPARATOR

Corticosteroid injection

Intervention Type PROCEDURE

Standard trigger finger corticosteroid injection.

Corticosteroid Injection and Trigger Splint

Corticosteroid Injection + Trigger Splint + Education + Home Exercises

Group Type EXPERIMENTAL

Corticosteroid injection + Trigger Splint+ Education and Home exercises

Intervention Type PROCEDURE

Standard corticosteroid injection. Hand based, single digit trigger splint will be applied. Education and instructions about home exercises.

Interventions

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Corticosteroid injection + Trigger Splint+ Education and Home exercises

Standard corticosteroid injection. Hand based, single digit trigger splint will be applied. Education and instructions about home exercises.

Intervention Type PROCEDURE

Corticosteroid injection

Standard trigger finger corticosteroid injection.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Philadelphia & South Jersey Hand Center

OTHER

Sponsor Role lead

Responsible Party

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Sidney M. Jacoby

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sidney Jacoby, MD

Role: STUDY_DIRECTOR

The Philadelphia and South Jersey Hand Center

Locations

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The Philadelphia and South Jersey Hand Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18406955 (View on PubMed)

Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. No abstract available.

Reference Type RESULT
PMID: 269967 (View on PubMed)

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.

Reference Type RESULT
PMID: 19006759 (View on PubMed)

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.

Reference Type RESULT
PMID: 1538090 (View on PubMed)

Other Identifiers

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11C.554

Identifier Type: -

Identifier Source: org_study_id

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