Effect of Lumbrical Stretching on Carpal Tunnel Syndrome

This study has been completed.

Sponsor:

Collaborator:

Arthritis Foundation

Information provided by (Responsible Party):

Nancy Baker, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00803257

First received: December 4, 2008

Last updated: June 12, 2012

Last verified: June 2012

History of Changes

Purpose

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.

Condition	Intervention
Carpal Tunnel Syndrome	Other: Lumbrical splint and Lumbrical exercises

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effect of Lumbrical Stretching on Carpal Tunnel Syndrome

Resource links provided by NLM:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Carpal Tunnel Syndrome Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Carpal Tunnel Syndrome Symptom Severity and Functional Status Scale (CTS-SSFS) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment:	124
Study Start Date:	March 2008
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Lumbrical splint and lumbrical stretches	Other: Lumbrical splint and Lumbrical exercises Subjects receive one of four possible interventions - Dose and Frequency are the same for each
Active Comparator: 2 Lumbrical Splint and regular exercises	Other: Lumbrical splint and Lumbrical exercises Subjects receive one of four possible interventions - Dose and Frequency are the same for each
Active Comparator: 3 Regular splint and lumbrical exercises	Other: Lumbrical splint and Lumbrical exercises Subjects receive one of four possible interventions - Dose and Frequency are the same for each
Active Comparator: 4 Regular splint and regular exercises	Other: Lumbrical splint and Lumbrical exercises Subjects receive one of four possible interventions - Dose and Frequency are the same for each

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803257

Locations

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260

Sponsors and Collaborators

University of Pittsburgh

Arthritis Foundation

More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Nancy Baker, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00803257 History of Changes
Other Study ID Numbers:	07030166
Study First Received:	December 4, 2008
Last Updated:	June 12, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Carpal Tunnel Syndrome
Splint
Hand exercises

Additional relevant MeSH terms:

Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases

Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013

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