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

Arm | Intervention/treatment |
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Experimental: Experimental
Custom-made splint and tendon-nerve gliding exercises Custom-made splint and no tendon-nerve gliding exercises
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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:
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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:
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- Carpal Tunnel Syndrome Symptom Severity & Functional Status Scale [ Time Frame: Pre-Post ]Self-report tool

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | 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.

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