Validation of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Cervical Spine Manipulation: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervicalgia
- Sponsor
- University of Nevada, Las Vegas
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Neck Disability Index
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to see if a recently developed clinical prediction rule (CPR) will successfully identify which patients with neck pain will respond rapidly and favorably to manipulation of their cervical spine.
Detailed Description
Consenting patients with a primary complaint of neck pain will be screened for contraindications to cervical spine manipulation and if eligible to participate in the study, will undergo a detailed subjective (history) and objective (physical) examination. At the completion of the examination, they will be assigned to one of two treatment arms - cervical manipulation and exercise or exercise only. They will receive up to 5 treatment sessions and be followed at 1 month, 3 months and 6 months after initial visit.
Investigators
Emilio J Puentedura, PT, DPT, PhD
Associate Professor
University of Nevada, Las Vegas
Eligibility Criteria
Inclusion Criteria
- •Primary complaint of mechanical neck pain with or without unilateral upper extremity symptoms (mechanical neck pain is defined as neck pain/ symptoms that are altered/ affected by activity, movement and posture)
- •NDI score at least 10 points out of 50.
Exclusion Criteria
- •Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, prolonged history of steroid use, etc.)
- •History of whiplash injury within the past six weeks
- •Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms
- •Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
- •Two or more positive neurologic signs consistent with nerve root compression, including any two of the following: a. Muscle weakness involving a major muscle group of the upper extremity b. Diminished upper extremity muscle stretch reflex (biceps brachii, Brachioradialis, or triceps reflex) c. Diminished or absent sensation to pinprick in any upper extremity dermatome
- •Prior surgery to the neck or thoracic spine
- •Pending legal action regarding their neck pain
- •Insufficient English language skills to complete all questionnaires
- •Inability to comply with treatment and follow-up schedule
Outcomes
Primary Outcomes
Neck Disability Index
Time Frame: 6 months
10-item patient self-report measure of perceived disability
Secondary Outcomes
- Medication Use(6 months)
- Global Rating of Change Scale(6 months)
- Numeric Pain Rating Scale(6 months)