Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (caregiver)|
Stage of finger triggering
time frame: 1, 2, 4-6, and 12 months
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
Male or female participants at least 18 years old.
- 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.
- 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
- Patients with impaired decision-making capacity
- Patients that do not speak English and cannot fill in English language questionnaires.
|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.|
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