NCT00803257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

2.8 years

First QC Date

December 4, 2008

Last Update Submit

June 12, 2012

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel SyndromeSplintHand exercises

Outcome Measures

Primary Outcomes (1)

  • Carpal Tunnel Syndrome Symptom Severity and Functional Status Scale (CTS-SSFS)

    1 month

Study Arms (4)

1

EXPERIMENTAL

Lumbrical splint and lumbrical stretches

Other: Lumbrical splint and Lumbrical exercises

2

ACTIVE COMPARATOR

Lumbrical Splint and regular exercises

Other: Lumbrical splint and Lumbrical exercises

3

ACTIVE COMPARATOR

Regular splint and lumbrical exercises

Other: Lumbrical splint and Lumbrical exercises

4

ACTIVE COMPARATOR

Regular splint and regular exercises

Other: Lumbrical splint and Lumbrical exercises

Interventions

Lumbrical splint and Lumbrical exercisesOTHER

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

1234

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 yo
  • Clinical symptoms of Carpal tunnel syndrome (CTS)
  • Positive Tinel's, Phalen's, or Durkin's test
  • Absence of thenar atrophy
  • pt discrimination of 5mm or less

You may not qualify if:

  • Persons needing immediate CTS surgery
  • Pregnancy
  • Compressive neuropathy in the ipsilateral arm
  • Diabetes
  • prior CTS release
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (2)

  • 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.

    PMID: 23925936DERIVED

  • 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.

    PMID: 22200381DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 4, 2008

First Posted

December 5, 2008

Study Start

March 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

US(1)