Effect of Lumbrical Stretching on Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Effect of Lumbrical Stretching on Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803257
• Other study ID #: 07030166
• Status: Completed
• Phase: N/A
• First received: December 4, 2008
• Last updated: June 12, 2012
• Start date: March 2008
• Est. completion date: January 2011

Study information

• Verified date: June 2012
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Symptoms of CTS occur when any condition decreases the size of the carpal canal or increases the volume of the structures within the carpal canal, compressing the median nerve. One cause of the symptoms of CTS is the incursion of the lumbrical muscles of the hand into the carpal canal. Individuals with CTS tend to have tight lumbrical muscles which increase this incursion, thereby increasing CTS symptoms. An intervention designed to reduce the incursion of the lumbrical muscles should have an effect on the symptoms of CTS.

The purpose of this study is to systematically examine the effect of an intensive lumbrical muscle intervention, splinting to prevent lumbrical muscle incursion and lumbrical muscle exercises, on the symptoms of CTS. This project will be a randomized clinical trial to evaluate the effectiveness of a home program targeting the lumbrical muscles. One hundred and twenty subjects will be assigned to one of 4 groups: Group 1 will receive a home program of lumbrical muscle stretches combined with a lumbrical positioning splint; Group 2 will receive a home program of lumbrical muscle stretches combined with a night wrist cock-up splint; Group 3 will receive a home program of general stretches combined with a lumbrical positioning splint; and Group 4 will receive a home program of general stretches combined with a night wrist cock-up splint. After 1 month, 3 months, and 6 months the groups will be compared to determine if there is a significant reduction in symptoms between the groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 yo

• Clinical symptoms of Carpal tunnel syndrome (CTS)

• Positive Tinel's, Phalen's, or Durkin's test

• Absence of thenar atrophy

• 2 pt discrimination of 5mm or less

Exclusion Criteria:

• Persons needing immediate CTS surgery

• Pregnancy

• Compressive neuropathy in the ipsilateral arm

• Diabetes

• prior CTS release

• Non-English speaking

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Other:
• Lumbrical splint and Lumbrical exercises
Subjects receive one of four possible interventions - Dose and Frequency are the same for each

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Arthritis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carpal Tunnel Syndrome Symptom Severity and Functional Status Scale (CTS-SSFS)		1 month	No