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

Trigger Finger Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01886157
• Other study ID #: 11C.554
• Status: Active, not recruiting
• Phase: N/A
• First received: June 21, 2013
• Last updated: March 17, 2015
• Start date: May 2013
• Est. completion date: May 2016

Study information

• Verified date: March 2015
• Source: The Philadelphia & South Jersey Hand Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stenosing Tenosynovitis
• Tendon Entrapment
• Tenosynovitis
• Trigger Finger
• Trigger Finger Disorder

Intervention

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.
• Corticosteroid injection
Standard trigger finger corticosteroid injection.

Locations

Country	Name	City	State
United States	The Philadelphia and South Jersey Hand Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
The Philadelphia & South Jersey Hand Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View Citation

Ring D, Lozano-Calderón 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. — View Citation

Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	Failed treatment: surgical intervention required	Failed treatment OR Successful treatment	1,2, 4-6, 12months	No
Secondary	Patient rated functional outcome	Quick Disabilities of the Arm, Shoulder and Hand questionnaire Patient Specific Functional Scale	1, 2, 4-6, 12months	No
Secondary	Pain	Visual Analog Scale	1, 2, 4-6, 12 months	No