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Mechanisms of Neural Mobilization in the Treatment of Chronic Pain

Primary Purpose

Carpal Tunnel Syndrome

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

neural mobilization

sham neural mobilization

healthy controls

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring manual therapy, carpal tunnel syndrome, central sensitization

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

neural mobilization

sham neural mobilization

Healthy Controls

Arm Description

manual therapy technique known to directly stress the median nerve

manual therapy technique known to directly stress the median nerve without any stimulation.

People without carpal tunnel syndrome for comparison

Outcomes

Primary Outcome Measures

thermal and pressure pain sensitivity

Secondary Outcome Measures

grip strength

wrist range of motion

clinical pain

self report of disability

median nerve function

Full Information

NCT ID

NCT00929123

First Posted

June 25, 2009

Last Updated

March 12, 2015

Sponsor

University of Florida

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT00929123

Brief Title

Mechanisms of Neural Mobilization in the Treatment of Chronic Pain

Official Title

Mechanisms of Neural Mobilization in the Treatment of Chronic Pain

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carpal Tunnel Syndrome

Keywords

manual therapy, carpal tunnel syndrome, central sensitization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

neural mobilization

Arm Type

Experimental

Arm Description

manual therapy technique known to directly stress the median nerve

Arm Title

sham neural mobilization

Arm Type

Placebo Comparator

Arm Description

manual therapy technique known to directly stress the median nerve without any stimulation.

Arm Title

Healthy Controls

Arm Type

Active Comparator

Arm Description

People without carpal tunnel syndrome for comparison

Intervention Type

Procedure

Intervention Name(s)

neural mobilization

Other Intervention Name(s)

upper limb tension test with median nerve bias

Intervention Description

manual therapy technique known to directly stress the median nerve

Intervention Type

Procedure

Intervention Name(s)

sham neural mobilization

Intervention Description

sham technique mimicking the neural mobilization which is not specific to the median nerve

Intervention Type

Other

Intervention Name(s)

healthy controls

Intervention Description

People without carpal tunnel syndrome for comparison

Primary Outcome Measure Information:

Title

thermal and pressure pain sensitivity

Time Frame

immediate effect

Secondary Outcome Measure Information:

Title

grip strength

Time Frame

3 weeks

Title

wrist range of motion

Time Frame

3 weeks

Title

clinical pain

Time Frame

3 weeks

Title

self report of disability

Time Frame

3 weeks

Title

median nerve function

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Z George, PhD

Organizational Affiliation

University of Florida Department of Physical Therapy

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32611

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19801812

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.2009.3117.

Results Reference

result

PubMed Identifier

21764354

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(6):602-8. doi: 10.1016/j.math.2011.06.003. Epub 2011 Jul 20.

Results Reference

result

PubMed Identifier

19027342

Citation

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.

Results Reference

result

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Mechanisms of Neural Mobilization in the Treatment of Chronic Pain

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