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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: Splint fabricated by an OT versus an off-the-shelf splint

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; Custom-made splint and tendon-nerve gliding exercises Custom-made splint and no tendon-nerve gliding exercises	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; Other Names: Control; Experimental
ACTIVE_COMPARATOR: Control; Off-the-shelf splint	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; Other Names: Control; Experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carpal Tunnel Syndrome Symptom Severity & Functional Status Scale	Self-report tool	Pre-Post

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Teresa L. Brininger, PhD, U.S. Army, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (ACTUAL): March 1, 2005
• Study Completion (ACTUAL): March 1, 2005

Study Registration Dates

• First Submitted: June 12, 2006
• First Submitted That Met QC Criteria: June 12, 2006
• First Posted (ESTIMATE): June 14, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): February 21, 2011
• Last Update Submitted That Met QC Criteria: February 18, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Carpal Tunnel Syndrome; Splints
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: 0402010