Effect of Lumbrical Stretching on Carpal Tunnel Syndrome

Official Title: “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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Lumbrical splint and lumbrical stretches
• Active Comparator: 2
  • Lumbrical Splint and regular exercises
• Active Comparator: 3
  • Regular splint and lumbrical exercises
• Active Comparator: 4
  • Regular splint and regular exercises

Primary Measures

• Carpal Tunnel Syndrome Symptom Severity and Functional Status Scale (CTS-SSFS)
  • Time Frame: 1 month
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Pittsburgh Other

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00803257

Study ID Number: 07030166

ClinicalTrials.gov Identifier: NCT00803257

Health Authority: United States: Institutional Review Board