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Thoracic Manipulation in Patients With Cervical Radiculopathy

This study is currently recruiting participants.
Verified December 2011 by Spine and Sport, Georgia
Sponsor:
Collaborator:
Virginia Commonwealth University
Information provided by (Responsible Party):
Spine and Sport, Georgia
ClinicalTrials.gov Identifier:
NCT01495728
First received: December 16, 2011
Last updated: December 19, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Cervical Radiculopathy
 Procedure: Thrust Manipulation - Thoracic Spine
Procedure: Sham Manipulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immediate and Short Term Effects of Thoracic Manipulation in Patients With Cervical Radiculopathy

Further study details as provided by Spine and Sport, Georgia:

Primary Outcome Measures:
  • Global Rating of Change [ Time Frame: Pre Treat, Immed, 48-72 hours ] [ Designated as safety issue: No ]
    Perceived Improvement

  • Numeric Pain Rating Scale (Neck & Upper Extremity) [ Time Frame: Pre Treat, Immed, 48-72 hrs ] [ Designated as safety issue: No ]
    Pain


Secondary Outcome Measures:
  • Neck Disability Index [ Time Frame: Pre Treat, Initial, 48-72 hours. ] [ Designated as safety issue: No ]
    Disability

  • Cervical Range of Motion [ Time Frame: Pre-treat, immediate post, 48-72 hours ] [ Designated as safety issue: No ]
  • Deep Neck Flexor Endurance [ Time Frame: Pre Treat, Immed, 48-72 hours ] [ Designated as safety issue: No ]
  • Numbness and Tingling Scale [ Time Frame: Pre Treat, Immed, 48-72 hours ] [ Designated as safety issue: No ]
    Rating of distal paresthesia/numbness


Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495728

Contacts
Contact: Ian A Young, PT, DSc 912-443-1400 youngian@spinesport.org

Locations
United States, Georgia
Spine and Sport Recruiting
Savannah, Georgia, United States, 31401
Contact: Ian A Young, PT, DSc     912-443-1400     youngian@spinesport.org    
Principal Investigator: Ian A Young, PT, DSc            
Sponsors and Collaborators
Spine and Sport, Georgia
Virginia Commonwealth University
Investigators
Principal Investigator: Ian A Young, PT, DSc Spine and Sport
  More Information

No publications provided

Responsible Party: Spine and Sport, Georgia
ClinicalTrials.gov Identifier: NCT01495728     History of Changes
Other Study ID Numbers: jacki2006
Study First Received: December 16, 2011
Last Updated: December 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Spine and Sport, Georgia:
Cervical Radiculopathy
Neck Pain
Manipulation

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013