Effect of Lumbrical Stretching on Carpal Tunnel Syndrome

NCT ID: NCT00803257

Last Updated: 2012-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Lumbrical splint and lumbrical stretches

Group Type EXPERIMENTAL

Lumbrical splint and Lumbrical exercises

Intervention Type OTHER

Subjects receive one of four possible interventions - Dose and Frequency are the same for each

2

Lumbrical Splint and regular exercises

Group Type ACTIVE_COMPARATOR

Lumbrical splint and Lumbrical exercises

Intervention Type OTHER

Subjects receive one of four possible interventions - Dose and Frequency are the same for each

3

Regular splint and lumbrical exercises

Group Type ACTIVE_COMPARATOR

Lumbrical splint and Lumbrical exercises

Intervention Type OTHER

Subjects receive one of four possible interventions - Dose and Frequency are the same for each

4

Regular splint and regular exercises

Group Type ACTIVE_COMPARATOR

Lumbrical splint and Lumbrical exercises

Intervention Type OTHER

Subjects receive one of four possible interventions - Dose and Frequency are the same for each

Interventions

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Lumbrical splint and Lumbrical exercises

Subjects receive one of four possible interventions - Dose and Frequency are the same for each

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arthritis Foundation

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Nancy Baker

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23925936 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22200381 (View on PubMed)

Other Identifiers

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07030166

Identifier Type: -

Identifier Source: org_study_id

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