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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01620905
Other study ID # UNLVPT08072806
Secondary ID
Status Completed
Phase N/A
First received June 13, 2012
Last updated June 13, 2012
Start date November 2008
Est. completion date June 2011

Study information

Verified date June 2012
Source University of Nevada, Las Vegas
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
Manipulation
Single level cervical spine joint manipulation

Locations

Country Name City State
United States UNLV PT Department Las Vegas Nevada

Sponsors (5)

Lead Sponsor Collaborator
University of Nevada, Las Vegas Franklin Pierce University, International Spine Pain Institute, Universidad Rey Juan Carlos, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Global Rating of Change Scale 15 point likert scale rating perceived recovery 48 hours post intervention No
Secondary 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 48 hours and 96 hours post intervention No
Secondary Neck Disability Index 10 item questionnaire measuring perceived disability (range 0 to 50) 48 hours and 96 hours post intervention No
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