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OpenTrials
Completed

NCT Number: NCT01620905

Development of a Clinical Prediction Rulefor Neck Manipulation

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.

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Key information

Conditions

Mechanical Neck Pain

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNLV PT Department

Las Vegas, Nevada, 89154, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manipulation

Procedure

Single level cervical spine joint manipulation

Primary outcomes

  1. Global Rating of Change Scale

    Time frame: 48 hours post intervention

    15 point likert scale rating perceived recovery

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Nevada, Las Vegas

Other

Collaborators

  • Franklin Pierce University
  • International Spine Pain Institute
  • Universidad Rey Juan Carlos
  • University of Colorado, Denver

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 15, 2012
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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