NCT00929123

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2007

Typical duration for phase_1

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

May 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

June 25, 2009

Last Update Submit

March 12, 2015

Conditions

Carpal Tunnel Syndrome

Keywords

manual therapycarpal tunnel syndromecentral sensitization

Outcome Measures

Primary Outcomes (1)

  • thermal and pressure pain sensitivity

    immediate effect

Secondary Outcomes (5)

  • grip strength

    3 weeks

  • wrist range of motion

    3 weeks

  • clinical pain

    3 weeks

  • self report of disability

    3 weeks

  • median nerve function

    3 weeks

Study Arms (3)

neural mobilization

EXPERIMENTAL

manual therapy technique known to directly stress the median nerve

Procedure: neural mobilization

sham neural mobilization

PLACEBO COMPARATOR

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

Procedure: sham neural mobilization

Healthy Controls

ACTIVE COMPARATOR

People without carpal tunnel syndrome for comparison

Other: healthy controls

Interventions

neural mobilizationPROCEDURE

manual therapy technique known to directly stress the median nerve

Also known as: upper limb tension test with median nerve bias
neural mobilization
sham neural mobilizationPROCEDURE

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

sham neural mobilization
healthy controlsOTHER

People without carpal tunnel syndrome for comparison

Healthy Controls

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 70 years of age
  • signs and symptoms of carpal tunnel syndrome for greater than 12 weeks

You may not qualify if:

  • non english speaking
  • prior surgery for carpal tunnel syndrome
  • systemic condition known to affect sensation
  • chronic pain condition other than carpal tunnel syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (3)

  • 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.

    PMID: 19801812RESULT

  • 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.

    PMID: 21764354RESULT

  • 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.

    PMID: 19027342RESULT

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 Officials

  • Steven Z George, PhD

    University of Florida Department of Physical Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2009

First Posted

June 26, 2009

Study Start

May 1, 2007

Primary Completion

July 1, 2008

Study Completion

June 1, 2009

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

US(1)