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

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Neck Pain
• Intervention / Treatment: Procedure: Manipulation

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89154
      • UNLV PT Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cervical spine manipulation; Subjects received cervical spine manipulation	Procedure: Manipulation; Single level cervical spine joint manipulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Rating of Change Scale	15 point likert scale rating perceived recovery	48 hours post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Neck Disability Index	10 item questionnaire measuring perceived disability (range 0 to 50)	48 hours and 96 hours post intervention

Collaborators and Investigators

• Sponsor: University of Nevada, Las Vegas
• Collaborators: University of Colorado, Denver; Universidad Rey Juan Carlos; Franklin Pierce University; International Spine Pain Institute

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 13, 2012
• First Submitted That Met QC Criteria: June 13, 2012
• First Posted (Estimate): June 15, 2012

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: UNLVPT08072806