Sponsor study identifier
interventional
124
1 country
1
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2011
Actual (reported)Study Completion
January 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
December 4, 2008
Actual (reported)December 5, 2008
Actual (reported)January 2011
Actual (reported)January 2011
Actual (reported)Carpal Tunnel Syndrome Symptom Severity and Functional Status Scale (CTS-SSFS)
1 month
Lumbrical splint and lumbrical stretches
Lumbrical Splint and regular exercises
Regular splint and lumbrical exercises
Subjects receive one of four possible interventions - Dose and Frequency are the same for each
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260, United States
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.
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.
124 participants (actual enrollment reported by the registry).
First Submitted
December 4, 2008
First Posted
December 5, 2008
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
The Effect of Surgical Incision Size on Carpal Tunnel Surgery
Regular splint and regular exercises
Contact the study team to confirm eligibility.
Primary Completion
January 2011
Actual (reported)Study Completion
January 2011
Actual (reported)Last Updated
June 13, 2012
Record last verified: 2012-06
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Source: ClinicalTrials.gov.
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