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

Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting: A Randomized Controlled Trial

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

Study Overview

• Status: Unknown
• Conditions: Trigger Finger; Stenosing Tenosynovitis
• Intervention / Treatment: Procedure: Corticosteroid injection; Procedure: Corticosteroid injection + Trigger Splint+ Education and Home exercises

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • The Philadelphia and South Jersey Hand Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Corticosteroid injection; Standard corticosteroid injection.	Procedure: Corticosteroid injection; Standard trigger finger corticosteroid injection.
Experimental: Corticosteroid Injection and Trigger Splint; Corticosteroid Injection + Trigger Splint + Education + Home Exercises	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1, 2, 4-6, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failed treatment: surgical intervention required	Failed treatment OR Successful treatment	1,2, 4-6, 12months
Patient rated functional outcome	Quick Disabilities of the Arm, Shoulder and Hand questionnaire Patient Specific Functional Scale	1, 2, 4-6, 12months
Pain	Visual Analog Scale	1, 2, 4-6, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance with splint and hand exercises	For patients who are assigned to injection and splint group, home exercise and splint compliance will be assessed by patients maintaining a case log.	1, 2 months

Collaborators and Investigators

• Sponsor: The Philadelphia & South Jersey Hand Center
• Investigators: Study Director: Sidney Jacoby, MD, The Philadelphia and South Jersey Hand Center

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: June 21, 2013
• First Submitted That Met QC Criteria: June 24, 2013
• First Posted (Estimate): June 25, 2013

Study Record Updates

• Last Update Posted (Estimate): March 18, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: trigger finger; orthotic intervention
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tenosynovitis; Trigger Finger Disorder; Tendon Entrapment
• Other Study ID Numbers: 11C.554