NCT00655915

Corticosteroid Injection as a Predictor of Outcome in Carpal Tunnel Release

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate whether symptomatic improvement following carpal tunnel corticosteroid injection can be correlated to symptomatic improvement following carpal tunnel release and therefore serve as a prognostic indicator. Clinical question: Does response to corticosteroid injection in CTS predict outcomes of surgical treatment? Secondary Questions: 1. Can we confirm previous retrospectively collected data that a certain percentage of conservatively managed patients with steroid injection will avoid surgery, and that patients who undergo surgery will have better outcomes than those who do not. 2. Are there differences between worker's compensation and non-worker's compensation patients with regard to the primary clinical question? 3. What are Carpal Tunnel Release outcomes for the subset of patients with negative electrophysiologic studies? 4. What are the outcomes of patients who undergo carpal tunnel release vs. those who choose not to undergo carpal tunnel release? A prospective cohort design study is the appropriate study design in order to measure the association between a predictor (response to injection) and outcome (response to surgery).

Detailed description

Carpal Tunnel Syndrome is a painful condition that is caused by compression of the median nerve in the wrist. Symptoms usually are pain, weakness, or numbness in the hand and wrist, radiating up the arm. Corticosteroid injections have been utilized in the conservative management of carpal tunnel syndrome for several decades. They have been shown to be relatively safe with a very low reported complication rate. Recent efforts in the literature have shown they are efficacious for a majority of patients although their effects are usually transient. Several studies have attempted to show a predictive value of corticosteroid injection with regard to who will ultimately benefit from carpal tunnel release. There is a trend towards positive predictability with several retrospective studies showing that patients who have a clinical benefit from steroid injection are more likely to have a successful outcome from carpal tunnel release. Carpal tunnel release remains the definitive treatment option for carpal tunnel syndrome, and a clinical test which could give the practitioner and patient additional information regarding likelihood of successful outcome of surgery would be a valuable prognostic tool.

Conditions

• Carpal Tunnel Syndrome

Interventions

Type	Name	Description
OTHER	Corticosteroid Injection- 1ml of Betamethasone and 1 ml of 1% Lidocaine	Patients will receive a carpal tunnel injection of 1 mg of betamethasone and 1 mL of 1% lidocaine will be infiltrated by small gauge (ie. 25- or 27-gauge) needle via attending surgeon preference. These are routinely performed by injecting 1cm proximal to distal wrist crease just ulnar to palmaris longus tendon although multiple techniques have been described. Elicitation of median nerve symptoms during needle placement requires redirecting needle prior to injection to avoid median nerve infiltration.

Timeline

• Start date: 2007-12-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2008-04-10
• Last updated: 2011-03-09

Locations

1 site across 1 country: United States