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Effect of Lumbrical Stretching on Carpal Tunnel Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00803257
First Posted: December 5, 2008
Last Update Posted: June 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Arthritis Foundation
Information provided by (Responsible Party):
Nancy Baker, University of Pittsburgh
December 4, 2008
December 5, 2008
June 13, 2012
March 2008
January 2011   (Final data collection date for primary outcome measure)
Carpal Tunnel Syndrome Symptom Severity and Functional Status Scale (CTS-SSFS) [ Time Frame: 1 month ]
Same as current
Complete list of historical versions of study NCT00803257 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Lumbrical Stretching on Carpal Tunnel Syndrome
Effect of Lumbrical Stretching on Carpal Tunnel Syndrome

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Carpal Tunnel Syndrome
Other: Lumbrical splint and Lumbrical exercises
Subjects receive one of four possible interventions - Dose and Frequency are the same for each
  • Experimental: 1
    Lumbrical splint and lumbrical stretches
    Intervention: Other: Lumbrical splint and Lumbrical exercises
  • Active Comparator: 2
    Lumbrical Splint and regular exercises
    Intervention: Other: Lumbrical splint and Lumbrical exercises
  • Active Comparator: 3
    Regular splint and lumbrical exercises
    Intervention: Other: Lumbrical splint and Lumbrical exercises
  • Active Comparator: 4
    Regular splint and regular exercises
    Intervention: Other: Lumbrical splint and Lumbrical exercises

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
January 2011
January 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00803257
07030166
Yes
Not Provided
Not Provided
Nancy Baker, University of Pittsburgh
University of Pittsburgh
Arthritis Foundation
Not Provided
University of Pittsburgh
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP