This trial is active, not recruiting.

Conditions trigger finger, stenosing tenosynovitis
Treatments corticosteroid injection + trigger splint+ education and home exercises, corticosteroid injection
Sponsor The Philadelphia & South Jersey Hand Center
Start date May 2013
End date December 2015
Trial size 100 participants
Trial identifier NCT01886157, 11C.554


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose treatment
(Active Comparator)
Standard corticosteroid injection.
corticosteroid injection
Standard trigger finger corticosteroid injection.
Corticosteroid Injection + Trigger Splint + Education + Home Exercises
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.

Primary Outcomes

Stage of finger triggering
time frame: 1, 2, 4-6, and 12 months

Secondary Outcomes

Failed treatment: surgical intervention required
time frame: 1,2, 4-6, 12months
Patient rated functional outcome
time frame: 1, 2, 4-6, 12months
time frame: 1, 2, 4-6, 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting: A Randomized Controlled Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by The Philadelphia & South Jersey Hand Center.