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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00929123
Other study ID # R21AT002796
Secondary ID R21AT002796R21AT
Status Completed
Phase Phase 1/Phase 2
First received June 25, 2009
Last updated March 12, 2015
Start date May 2007
Est. completion date June 2009

Study information

Verified date March 2015
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study was to determine the effect of a manual therapy technique (neural mobilization) on measures of clinical pain and function, experimental pain sensitivity, and on the function of the median nerve in individuals with carpal tunnel syndrome. The investigators hypothesized that individuals receiving a neural mobilization technique known to directly stress the median nerve would demonstrate greater improvements in clinical pain and function, experimental pain sensitivity, and median nerve function than those receiving a sham technique.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2009
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 18 to 70 years of age

- signs and symptoms of carpal tunnel syndrome for greater than 12 weeks

Exclusion Criteria:

- non english speaking

- prior surgery for carpal tunnel syndrome

- systemic condition known to affect sensation

- chronic pain condition other than carpal tunnel syndrome

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
neural mobilization
manual therapy technique known to directly stress the median nerve
sham neural mobilization
sham technique mimicking the neural mobilization which is not specific to the median nerve
Other:
healthy controls
People without carpal tunnel syndrome for comparison

Locations

Country Name City State
United States University of Florida Gainesville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21. — View Citation

Bialosky JE, Bishop MD, Price DD, Robinson ME, Vincent KR, George SZ. A randomized sham-controlled trial of a neurodynamic technique in the treatment of carpal tunnel syndrome. J Orthop Sports Phys Ther. 2009 Oct;39(10):709-23. doi: 10.2519/jospt.2009.311 — View Citation

Bialosky JE, Bishop MD, Robinson ME, Price DD, George SZ. Heightened pain sensitivity in individuals with signs and symptoms of carpal tunnel syndrome and the relationship to clinical outcomes following a manual therapy intervention. Man Ther. 2011 Dec;16 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary thermal and pressure pain sensitivity immediate effect No
Secondary grip strength 3 weeks No
Secondary wrist range of motion 3 weeks No
Secondary clinical pain 3 weeks No
Secondary self report of disability 3 weeks No
Secondary median nerve function 3 weeks No
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