Status
Conditions
Treatments
About
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.
Full 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:
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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.
Primary purpose
Allocation
Interventional model
Masking
56 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal