Mechanisms of Neural Mobilization in the Treatment of Chronic Pain

This study has been completed.

Sponsor:

Collaborator:

National Center for Complementary and Alternative Medicine (NCCAM)

Information provided by (Responsible Party):

University of Florida

ClinicalTrials.gov Identifier:

NCT00929123

First received: June 25, 2009

Last updated: December 21, 2011

Last verified: June 2010

History of Changes

Purpose

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.

Condition	Intervention	Phase
Carpal Tunnel Syndrome	Procedure: neural mobilization Procedure: sham neural mobilization Other: healthy controls	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Mechanisms of Neural Mobilization in the Treatment of Chronic Pain

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 Chronic Pain

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

thermal and pressure pain sensitivity [ Time Frame: immediate effect ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

grip strength [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
wrist range of motion [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
clinical pain [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
self report of disability [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
median nerve function [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	May 2007
Study Completion Date:	June 2009
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: neural mobilization manual therapy technique known to directly stress the median nerve	Procedure: neural mobilization manual therapy technique known to directly stress the median nerve Other Name: upper limb tension test with median nerve bias
Placebo Comparator: sham neural mobilization	Procedure: sham neural mobilization sham technique mimicking the neural mobilization which is not specific to the median nerve
No Intervention: Healthy Controls People without carpal tunnel syndrome for comparison	Other: healthy controls People without carpal tunnel syndrome for comparison

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929123

Locations

United States, Florida
University of Florida
Gainesville, Florida, United States, 32611

Sponsors and Collaborators

University of Florida

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Steven Z George, PhD

University of Florida Department of Physical Therapy

More Information

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.

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. 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. Epub 2008 Nov 21.

Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT00929123 History of Changes
Other Study ID Numbers:	R21 AT002796, R21AT002796, R21 AT002796-01A1
Study First Received:	June 25, 2009
Last Updated:	December 21, 2011
Health Authority:	United States: Federal Government

Keywords provided by University of Florida:

manual therapy
carpal tunnel syndrome
central sensitization

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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