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Development of a Clinical Prediction Rulefor Neck Manipulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01620905
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : May 12, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
Cervical spine manipulation has been shown to be helpful for some patients with neck pain. This study sought to determine factors which were predictive of which patients with neck pain would benefit from manipulation.

Condition or disease Intervention/treatment
Mechanical Neck Pain Procedure: Manipulation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Cervical Spine Manipulation and Exercise
Study Start Date : November 2008
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cervical spine manipulation
Subjects received cervical spine manipulation
Procedure: Manipulation
Single level cervical spine joint manipulation

Outcome Measures

Primary Outcome Measures :
  1. Global Rating of Change Scale [ Time Frame: 48 hours post intervention ]
    15 point likert scale rating perceived recovery

Secondary Outcome Measures :
  1. Numeric Pain Rating Scale [ Time Frame: 48 hours and 96 hours post intervention ]
    Average pain scores (0 - no pain to 10 - worst imaginable pain) taken for current rating, best in last 24 hours and worst in last 24 hours

  2. Neck Disability Index [ Time Frame: 48 hours and 96 hours post intervention ]
    10 item questionnaire measuring perceived disability (range 0 to 50)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age 18 to 60 years
  • primary report of neck pain with or without unilateral upper extremity symptoms
  • baseline neck disability index score of 10 points (out of 50) or greater

Exclusion Criteria:

  • any medical red flags suggesting that the etiology of symptoms might be nonmusculoskeletal
  • diagnosis of cervical spinal stenosis (as identified in the patients' medical intake form)
  • bilateral upper extremity symptoms
  • evidence of central nervous system involvement
  • history of whiplash injury within 6 weeks of the examination
  • pending legal action regarding their neck pain
  • 2 or more positive neurologic signs consistent with nerve root compression (changes in sensation, myotomal weakness, or decreased deep tendon reflexes)
  • any history of cervical spine surgery, rheumatoid arthritis, osteoporosis, osteopenia, or ankylosing spondylitis.
Contacts and Locations

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): NCT01620905

United States, Nevada
UNLV PT Department
Las Vegas, Nevada, United States, 89154
Sponsors and Collaborators
University of Nevada, Las Vegas
Franklin Pierce University
University of Colorado, Denver
International Spine Pain Institute
Universidad Rey Juan Carlos
More Information

Responsible Party: Emilio J Puentedura, PT, DPT, PhD, Associate Professor, University of Nevada, Las Vegas
ClinicalTrials.gov Identifier: NCT01620905     History of Changes
Other Study ID Numbers: UNLVPT08072806
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Neck Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms