Development of a CPR for Neck Manipulation

Mechanical Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620905
• Other study ID #: UNLVPT08072806
• 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

• Mechanical Neck Pain
• Neck Pain

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