Effect of Lumbrical Stretching on Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumbrical splint and Lumbrical exercises
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Syndrome, Splint, Hand exercises
Eligibility Criteria
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
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
Arm Description
Lumbrical splint and lumbrical stretches
Lumbrical Splint and regular exercises
Regular splint and lumbrical exercises
Regular splint and regular exercises
Outcomes
Primary Outcome Measures
Carpal Tunnel Syndrome Symptom Severity and Functional Status Scale (CTS-SSFS)
Secondary Outcome Measures
Full Information
NCT ID
NCT00803257
First Posted
December 4, 2008
Last Updated
June 12, 2012
Sponsor
University of Pittsburgh
Collaborators
Arthritis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00803257
Brief Title
Effect of Lumbrical Stretching on Carpal Tunnel Syndrome
Official Title
Effect of Lumbrical Stretching on Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Arthritis Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal Tunnel Syndrome, Splint, Hand exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Lumbrical splint and lumbrical stretches
Arm Title
2
Arm Type
Active Comparator
Arm Description
Lumbrical Splint and regular exercises
Arm Title
3
Arm Type
Active Comparator
Arm Description
Regular splint and lumbrical exercises
Arm Title
4
Arm Type
Active Comparator
Arm Description
Regular splint and regular exercises
Intervention Type
Other
Intervention Name(s)
Lumbrical splint and Lumbrical exercises
Intervention Description
Subjects receive one of four possible interventions - Dose and Frequency are the same for each
Primary Outcome Measure Information:
Title
Carpal Tunnel Syndrome Symptom Severity and Functional Status Scale (CTS-SSFS)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23925936
Citation
Baker NA, Moehling KK, Desai AR, Gustafson NP. Effect of carpal tunnel syndrome on grip and pinch strength compared with sex- and age-matched normative data. Arthritis Care Res (Hoboken). 2013 Dec;65(12):2041-5. doi: 10.1002/acr.22089.
Results Reference
derived
PubMed Identifier
22200381
Citation
Baker NA, Moehling KK, Rubinstein EN, Wollstein R, Gustafson NP, Baratz M. The comparative effectiveness of combined lumbrical muscle splints and stretches on symptoms and function in carpal tunnel syndrome. Arch Phys Med Rehabil. 2012 Jan;93(1):1-10. doi: 10.1016/j.apmr.2011.08.013.
Results Reference
derived
Learn more about this trial
Effect of Lumbrical Stretching on Carpal Tunnel Syndrome
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