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Trial record 1 of 1 for:    NCT01495728
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Thoracic Manipulation in Patients With Cervical Radiculopathy

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ClinicalTrials.gov Identifier: NCT01495728
Recruitment Status : Unknown
Verified December 2011 by Spine and Sport, Georgia.
Recruitment status was:  Recruiting
First Posted : December 20, 2011
Last Update Posted : December 20, 2011
Sponsor:
Collaborator:
Virginia Commonwealth University
Information provided by (Responsible Party):
Spine and Sport, Georgia

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cervical Radiculopathy Procedure: Thrust Manipulation - Thoracic Spine Procedure: Sham Manipulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immediate and Short Term Effects of Thoracic Manipulation in Patients With Cervical Radiculopathy
Study Start Date : September 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : August 2012
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Global Rating of Change [ Time Frame: Pre Treat, Immed, 48-72 hours ]
    Perceived Improvement

  2. Numeric Pain Rating Scale (Neck & Upper Extremity) [ Time Frame: Pre Treat, Immed, 48-72 hrs ]
    Pain


Secondary Outcome Measures :
  1. Neck Disability Index [ Time Frame: Pre Treat, Initial, 48-72 hours. ]
    Disability

  2. Cervical Range of Motion [ Time Frame: Pre-treat, immediate post, 48-72 hours ]
  3. Deep Neck Flexor Endurance [ Time Frame: Pre Treat, Immed, 48-72 hours ]
  4. Numbness and Tingling Scale [ Time Frame: Pre Treat, Immed, 48-72 hours ]
    Rating of distal paresthesia/numbness


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495728


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

Locations
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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
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Principal Investigator: Ian A Young, PT, DSc Spine and Sport
More Information
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Responsible Party: Spine and Sport, Georgia
ClinicalTrials.gov Identifier: NCT01495728    
Other Study ID Numbers: jacki2006
First Posted: December 20, 2011    Key Record Dates
Last Update Posted: December 20, 2011
Last Verified: December 2011
Keywords provided by Spine and Sport, Georgia:
Cervical Radiculopathy
Neck Pain
Manipulation
Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases