Validation of CPR for Manipulation for Neck Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Validation of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Cervical Spine Manipulation: A Randomized Clinical Trial

Conditions
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Cervicalgia

Intervention / Treatment
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* Procedure: Manipulation
* Procedure: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manipulation<br>Patients will receive cervical manipulation on 2 visits and then a further 3 visits of therapeutic exercises | Procedure: Manipulation<br>* High velocity low amplitude thrust joint manipulation to cervical spine facet joints<br>Procedure: Exercise<br>* Therapeutic exercises to the cervical, thoracic and scapular musculature<br>|
| Other: Exercise<br>Patients will receive 5 visits of therapeutic exercises | Procedure: Exercise<br>* Therapeutic exercises to the cervical, thoracic and scapular musculature<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index | 10-item patient self-report measure of perceived disability | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Use |  | 6 months | 
| Global Rating of Change Scale |  | 6 months | 
| Numeric Pain Rating Scale |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neck pain