Back to resultsDevelopment of a Clinical Prediction Rulefor Neck Manipulation
Primary Purpose
Mechanical Neck Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manipulation
Sponsored by
About this trial
This is an interventional diagnostic trial for Mechanical Neck Pain
Eligibility Criteria
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.
Sites / Locations
- UNLV PT Department
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cervical spine manipulation
Arm Description
Subjects received cervical spine manipulation
Outcomes
Primary Outcome Measures
Global Rating of Change Scale
15 point likert scale rating perceived recovery
Secondary Outcome Measures
Numeric Pain Rating Scale
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
Neck Disability Index
10 item questionnaire measuring perceived disability (range 0 to 50)
Full Information
NCT ID
NCT01620905
First Posted
June 13, 2012
Last Updated
May 10, 2016
Sponsor
University of Nevada, Las Vegas
Collaborators
Franklin Pierce University, University of Colorado, Denver, International Spine Pain Institute, Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT01620905
Brief Title
Development of a Clinical Prediction Rulefor Neck Manipulation
Official Title
Development of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Cervical Spine Manipulation and Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas
Collaborators
Franklin Pierce University, University of Colorado, Denver, International Spine Pain Institute, Universidad Rey Juan Carlos
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Neck Pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervical spine manipulation
Arm Type
Experimental
Arm Description
Subjects received cervical spine manipulation
Intervention Type
Procedure
Intervention Name(s)
Manipulation
Intervention Description
Single level cervical spine joint manipulation
Primary Outcome Measure Information:
Title
Global Rating of Change Scale
Description
15 point likert scale rating perceived recovery
Time Frame
48 hours post intervention
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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
Time Frame
48 hours and 96 hours post intervention
Title
Neck Disability Index
Description
10 item questionnaire measuring perceived disability (range 0 to 50)
Time Frame
48 hours and 96 hours post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
UNLV PT Department
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States
12. IPD Sharing Statement
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Development of a Clinical Prediction Rulefor Neck Manipulation
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