Clinical trial NCT01886157: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Trigger Finger
Stenosing Tenosynovitis
Keywords: trigger finger
orthotic intervention
Lead sponsor: The Philadelphia & South Jersey Hand Center
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Stage of finger triggering
timeFrame: 1, 2, 4-6, and 12 months
Secondary outcomes:
measure: Failed treatment: surgical intervention required
timeFrame: 1,2, 4-6, 12months
measure: Patient rated functional outcome
timeFrame: 1, 2, 4-6, 12months
measure: Pain
timeFrame: 1, 2, 4-6, 12 months
Other outcomes:
measure: Compliance with splint and hand exercises
timeFrame: 1, 2 months
Locations:
city: Philadelphia
country: United States
facility: The Philadelphia and South Jersey Hand Center
state: Pennsylvania
Study officials:
affiliation: The Philadelphia and South Jersey Hand Center
name: Sidney Jacoby, MD
role: STUDY_DIRECTOR
References:
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.
citation: Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. No abstract available.
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.
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.