Thoracic Manipulation in Patients With Cervical Radiculopathy

December 19, 2011 updated by: Spine and Sport, Georgia

Immediate and Short Term Effects of Thoracic Manipulation in Patients With Cervical Radiculopathy

Hypothesis: The group of Cervical Radiculopathy patients receiving thoracic thrust manipulation will demonstrate immediate and short term significant clinically important changes in outcomes when compared to the sham manipulation group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

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

  • United States
    • Georgia
      • Savannah, Georgia, United States, 31401
        • Recruiting
        • Spine and Sport
        • Contact:
        • Principal Investigator:
          • Ian A Young, PT, DSc

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-65 yrs
  • 3 out 4 Items positive of Clinical Prediction Rule for Cervical Radiculopathy

Exclusion Criteria:

  • history of previous cervical or thoracic spine surgery
  • bilateral upper-extremity symptoms, signs or symptoms of upper motor neuron disease,
  • medical "red flags" (e.g., tumor, fracture, rheumatoid arthritis, osteoporosis, and prolonged steroid use).

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Thrust Manipulation -Thoracic Spine
Mid and Upper Thoracic Spine
Procedure: Thrust Manipulation - Thoracic Spine
Mid and Upper Thoracic Spine
PLACEBO_COMPARATOR: Sham Manipulation
Mid and Upper Thoracic Spine
Procedure: Sham Manipulation
Mid and Upper Thoracic Spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Rating of Change
Time Frame: Pre Treat, Immed, 48-72 hours
Perceived Improvement
Pre Treat, Immed, 48-72 hours
Numeric Pain Rating Scale (Neck & Upper Extremity)
Time Frame: Pre Treat, Immed, 48-72 hrs
Pain
Pre Treat, Immed, 48-72 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck Disability Index
Time Frame: Pre Treat, Initial, 48-72 hours.
Disability
Pre Treat, Initial, 48-72 hours.
Cervical Range of Motion
Time Frame: Pre-treat, immediate post, 48-72 hours
Pre-treat, immediate post, 48-72 hours
Deep Neck Flexor Endurance
Time Frame: Pre Treat, Immed, 48-72 hours
Pre Treat, Immed, 48-72 hours
Numbness and Tingling Scale
Time Frame: Pre Treat, Immed, 48-72 hours
Rating of distal paresthesia/numbness
Pre Treat, Immed, 48-72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spine and Sport, Georgia

Collaborators

Virginia Commonwealth University

Investigators

  • Principal Investigator: Ian A Young, PT, DSc, Spine and Sport

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

September 1, 2011

Primary Completion (ANTICIPATED)

July 1, 2012

Study Completion (ANTICIPATED)

August 1, 2012

Study Registration Dates

First Submitted

December 16, 2011

First Submitted That Met QC Criteria

December 19, 2011

First Posted (ESTIMATE)

December 20, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 20, 2011

Last Update Submitted That Met QC Criteria

December 19, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • jacki2006

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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