Clinical Trial: Efficacy of Wrist/Hand Splints and Tendon/Nerve Gliding Exercises for Carpal Tunnel Syndrome: A RCT

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Efficacy of a Wrist and Hand Splint in Conjunction With Tendon and Nerve Gliding Exercise for the Treatment of Carpal Tunnel Syndrome: A Randomized Clinical Trial

Brief Summary: The purpose of this randomized clinical trial was to examine the efficacy of a splinting (fabricated versus off-the-shelf splint)and exercise (nerve and tendon gliding versus no exercise) interventions to alter the clinical course of Carpal Tunnel Syndrome (CTS). We hypothesized that the fabricated splint with nerve and tendon gliding exercises condition would yield the best functional outcomes at 4 and 8 weeks posttesting.

Detailed Summary:

The purpose of this randomized clinical trial is to examine the efficacy of a splinting and exercise intervention to alter the clinical course of Carpal Tunnel Syndrome (CTS). Specifically, the aims of the study are to test the efficacy of: (1) a splint, positioning the wrist and metacarpal phalange (MCP) joints at 0 degrees in conjunction with tendon and nerve gliding exercises, (2) a splint positioning the wrist and MCP joints at 0 degrees with no exercise (3) a prefabricated wrist cock up splint positioning the wrist at 20 degrees of extension with tendon and nerve gliding exercises, and (4) usual care, a prefabricated wrist cock-up splint positioning the wrist at 20 degrees of extension with no exercise for decreasing symptoms and increasing function in people with clinically diagnosed CTS. The specific hypotheses of the study are:

(1) Subjects randomized to Experimental Condition 1 will perform better than Subjects randomized to Experimental Condition 2; who will perform better than those randomized to Experimental Condition 3, who in turn will perform better than those Subjects randomized to Usual Care. In that order, Subjects will demonstrate a:

  1. Significant decrease in CTS symptoms as measured by the Carpal Tunnel Syndrome Symptom Severity Scale at the 4 week Posttest compared to baseline and further decrease at the 8 week Post-Posttest.
  2. Significant decrease in upper extremity disability as measured by the Disability of Arm, Shoulder, and Hand (DASH) questionnaire at the 4 week Posttest compared to baseline and further decrease at the 8 week Post-Posttest.
  3. Significant increase in functional ability as measured by functional sensibility (Moberg Pick-Up Test), grip strength (dynamometer) and pinch strength (pinch mete
    Sponsor: University of Pittsburgh

    Current Primary Outcome: Carpal Tunnel Syndrome Symptom Severity & Functional Status Scale [ Time Frame: Pre-Post ]

    Self-report tool


    Original Primary Outcome: Carpal Tunnel Syndrome Symptom Severity & Functional Status Scale

    Current Secondary Outcome:

    Original Secondary Outcome:

    • Semmes and Weinstein Monofilament Sensory Test
    • Disabilities of Arm, Shoulder and Hand
    • Jamar Dynamometer
    • Moberg Pick-Up Test
    • Patient Satisfaction
    • Clinical measures (intrinsic tightness, pinch strength)


    Information By: University of Pittsburgh

    Dates:
    Date Received: June 12, 2006
    Date Started: June 2004
    Date Completion:
    Last Updated: February 18, 2011
    Last Verified: February 2011