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

NCT ID: NCT00336622

Last Updated: 2011-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2005-03-31

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 Description

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Custom-made splint and tendon-nerve gliding exercises Custom-made splint and no tendon-nerve gliding exercises

Group Type: EXPERIMENTAL

Splint fabricated by an OT versus an off-the-shelf splint

Intervention Type: DEVICE

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

Control

Off-the-shelf splint

Group Type: ACTIVE_COMPARATOR

Splint fabricated by an OT versus an off-the-shelf splint

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Experimental; Control

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

University of Pittsburgh

Principal Investigators

Teresa L. Brininger, PhD

Role: PRINCIPAL_INVESTIGATOR

U.S. Army, University of Pittsburgh

Other Identifiers

0402010

Identifier Type: -

Identifier Source: org_study_id