Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336622
Status:
COMPLETED
Last Update Posted:
2011-02-21
First Post:
2006-06-12
Brief Title:
Efficacy of WristHand Splints and TendonNerve Gliding Exercises for Carpal Tunnel Syndrome A RCT
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this randomized clinical trial was to examine the efficacy of a splinting fabricated versus off-the-shelf splintand 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None