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

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”

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.

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 meter) at the 4 week Posttest compared to baseline.

Intervention(s) in this Clinical Trial

• Device: Splint fabricated by an OT versus an off-the-shelf splint
  • Experimental: Custom-made splint and tendon-nerve gliding exercises Custom-made splint and no tendon-nerve gliding exercises Control: Control: Off-the-shelf splint and tendon-nerve gliding exercises Off-the-shelf splint and no tendon-nerve gliding exercises

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Experimental
  • Custom-made splint and tendon-nerve gliding exercises Custom-made splint and no tendon-nerve gliding exercises
• Active Comparator: Control
  • Off-the-shelf splint

Primary Measures

• Carpal Tunnel Syndrome Symptom Severity & Functional Status Scale
  • Time Frame: Pre-Post
    Safety Issue?: No

• Inclusion Criteria: (1) be at least 18 years of age; (2) have positive Tinels, Phalens, and complaints of nocturnal numbness and tingling. (3) English speaking. The exclusion criteria are; (1) have been diagnosed with a neuropathy other than CTS in the past year (2) pregnant (3) have had a steroid injection into the carpal canal in the past 3 months (4) have thenar atrophy (5) have had a prior carpal tunnel release.
• Exclusion Criteria: Pregnant women will be excluded from the study. There is an increased incidence of CTS in pregnant women; however symptoms usually decrease after pregnancy.
• Thus, it would be difficult to determine if the intervention was effective or if the symptoms resolved after the birth of the child. The physician will rule out pregnancy by patient report. Also, no minors will be included in this study because CTS is not a diagnosis common to minors.
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Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Pittsburgh Other

Overall Clinical Trial Officials and Contacts

Teresa L. Brininger, PhD Principal Investigator U.S. Army, University of Pittsburgh  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00336622

Study ID Number: 0402010

ClinicalTrials.gov Identifier: NCT00336622

Health Authority: United States: Food and Drug Administration