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

Not Applicable

• Conditions: Stenosing Tenosynovitis; Trigger Finger

• Registration Number: NCT01886157
• Lead Sponsor: The Philadelphia & South Jersey Hand Center

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-21
• Study First Submitted QC: 2013-06-24
• Study First Posted: 2013-06-25
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18
• Primary Completion: 2015-12
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stage of finger triggering	1, 2, 4-6, and 12 months	Trigger Finger Stage: 1. Normal; 2. Painful palpable nodule; 3. Triggering = Clicking = Catching; 4. Locking of finger in flexion or extension unlocked by active finger movement; 5. Locking of finger in flexion or extension unlocked by passive finger movement; 6. Locked finger in flexion or extension (Each stage may be painless or painful)

Secondary Outcome Measures

Name	Time	Method
Failed treatment: surgical intervention required	1,2, 4-6, 12months	Failed treatment OR Successful treatment
Patient rated functional outcome	1, 2, 4-6, 12months	Quick Disabilities of the Arm, Shoulder and Hand questionnaire Patient Specific Functional Scale
Pain	1, 2, 4-6, 12 months	Visual Analog Scale

Trial Locations

Locations (1)

The Philadelphia and South Jersey Hand Center; 🇺🇸 Philadelphia, Pennsylvania, United States