- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00929123
Mechanisms of Neural Mobilization in the Treatment of Chronic Pain
March 12, 2015 updated by: University of Florida
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32611
- University of Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: neural mobilization
manual therapy technique known to directly stress the median nerve
|
manual therapy technique known to directly stress the median nerve
Other Names:
|
Placebo Comparator: sham neural mobilization
manual therapy technique known to directly stress the median nerve without any stimulation.
|
sham technique mimicking the neural mobilization which is not specific to the median nerve
|
Active Comparator: Healthy Controls
People without carpal tunnel syndrome for comparison
|
People without carpal tunnel syndrome for comparison
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
thermal and pressure pain sensitivity
Time Frame: immediate effect
|
immediate effect
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
grip strength
Time Frame: 3 weeks
|
3 weeks
|
wrist range of motion
Time Frame: 3 weeks
|
3 weeks
|
clinical pain
Time Frame: 3 weeks
|
3 weeks
|
self report of disability
Time Frame: 3 weeks
|
3 weeks
|
median nerve function
Time Frame: 3 weeks
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steven Z George, PhD, University of Florida Department of Physical Therapy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.2009.3117.
- 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(6):602-8. doi: 10.1016/j.math.2011.06.003. Epub 2011 Jul 20.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
June 25, 2009
First Submitted That Met QC Criteria
June 25, 2009
First Posted (Estimate)
June 26, 2009
Study Record Updates
Last Update Posted (Estimate)
March 17, 2015
Last Update Submitted That Met QC Criteria
March 12, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT002796 (U.S. NIH Grant/Contract)
- R21AT002796-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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