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Development of a Clinical Prediction Rulefor Neck Manipulation

Development of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Cervical Spine Manipulation and Exercise

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01620905
Enrollment
82
Registered
2012-06-15
Start date
2008-11-30
Completion date
2011-06-30
Last updated
2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Neck Pain

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.

Interventions

PROCEDUREManipulation

Single level cervical spine joint manipulation

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Global Rating of Change Scale48 hours post intervention15 point likert scale rating perceived recovery

Secondary

MeasureTime frameDescription
Neck Disability Index48 hours and 96 hours post intervention10 item questionnaire measuring perceived disability (range 0 to 50)
Numeric Pain Rating Scale48 hours and 96 hours post interventionAverage 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026