Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting
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|ClinicalTrials.gov Identifier: NCT01886157|
Recruitment Status : Unknown
Verified March 2015 by Sidney M. Jacoby, The Philadelphia & South Jersey Hand Center.
Recruitment status was: Active, not recruiting
First Posted : June 25, 2013
Last Update Posted : March 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Trigger Finger Stenosing Tenosynovitis||Procedure: Corticosteroid injection + Trigger Splint+ Education and Home exercises Procedure: Corticosteroid injection||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting: A Randomized Controlled Trial|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||May 2016|
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.
- Stage of finger triggering [ Time Frame: 1, 2, 4-6, and 12 months ]
Trigger Finger Stage:
- 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)
- Failed treatment: surgical intervention required [ Time Frame: 1,2, 4-6, 12months ]Failed treatment OR Successful treatment
- Patient rated functional outcome [ Time Frame: 1, 2, 4-6, 12months ]Quick Disabilities of the Arm, Shoulder and Hand questionnaire Patient Specific Functional Scale
- Pain [ Time Frame: 1, 2, 4-6, 12 months ]Visual Analog Scale
- Compliance with splint and hand exercises [ Time Frame: 1, 2 months ]For patients who are assigned to injection and splint group, home exercise and splint compliance will be assessed by patients maintaining a case log.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886157
|United States, Pennsylvania|
|The Philadelphia and South Jersey Hand Center|
|Philadelphia, Pennsylvania, United States, 19107|
|Study Director:||Sidney Jacoby, MD||The Philadelphia and South Jersey Hand Center|