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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00336622
Enrollment
56
Registered
2006-06-14
Start date
2004-06-30
Completion date
2005-03-31
Last updated
2011-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome, Splints

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.

Interventions

DEVICESplint 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

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Carpal Tunnel Syndrome Symptom Severity & Functional Status ScalePre-PostSelf-report tool

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026