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

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ClinicalTrials.gov Identifier: NCT00336622

Recruitment Status : Completed

First Posted : June 14, 2006

Last Update Posted : February 21, 2011

Sponsor:

Information provided by:

University of Pittsburgh

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Carpal Tunnel Syndrome	Device: Splint fabricated by an OT versus an off-the-shelf splint	Not Applicable

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:

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.
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.
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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	56 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	June 2004
Actual Primary Completion Date :	March 2005
Actual Study Completion Date :	March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Carpal Tunnel Syndrome Exercise and Physical Fitness

Genetic and Rare Diseases Information Center resources: Charcot-Marie-Tooth Disease Hereditary Neuropathy With Liability to Pressure Palsy Roussy Levy Syndrome

U.S. FDA Resources

Arms and Interventions

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: Experimental Control
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: Experimental Control

Outcome Measures

Primary Outcome Measures :

Carpal Tunnel Syndrome Symptom Severity & Functional Status Scale [ Time Frame: Pre-Post ]
Self-report tool

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00336622

Sponsors and Collaborators

University of Pittsburgh

Investigators


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

More Information


Responsible Party:	Joan C. Rogers, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00336622 History of Changes
Other Study ID Numbers:	0402010
First Posted:	June 14, 2006 Key Record Dates
Last Update Posted:	February 21, 2011
Last Verified:	February 2011

Keywords provided by University of Pittsburgh:


Carpal Tunnel Syndrome Splints

Additional relevant MeSH terms:


Syndrome Carpal Tunnel Syndrome Nerve Compression Syndromes Disease Pathologic Processes Median Neuropathy Mononeuropathies	Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries

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