Chiropractic Manual Therapy and Neck Pain

Study Overview
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Brief Summary
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Eligible subjects with chronic neck pain will be randomly allocated to one of two intervention groups: real vs control spinal manipulation. They will receive three intervention sessions. H1: Chronic neck pain patients treated longitudinally over a series of three encounters in one week by random assignment to treatment group with either of the dual delivery procedures (Intervention 1=typical-control or Intervention 2=control-control) will have a 50% error rate of self-report of group allocation at exit interview. H2: Patients treated by the typical-control dual procedure over a typical sequence of encounters (3 times in one week) will show statistically significant improvement in clinical outcomes; defined quantitatively by visual analogue pain scale (VAS), Neck Disability Index (NDI), range of motion and pressure algometry; compared to those treated by the control-control dual procedure. H3: Patients stratified by 'a priori' patient expectation for treatment outcome will show no significant difference in self-report of group allocation or clinical outcome measures. A total of 372 subjects will be recruited.

Official Title
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Generalizing a Valid Control Manipulation to a Multiple Operator, Longitudinal Randomized Controlled Study for Chronic Neck Pain

Conditions
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Chronic Mechanical Neck Pain

Intervention / Treatment
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* Procedure: Spinal manipulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female 21 to 60 years of age Chronic neck pain Neck pain duration greater than 6 weeks Numeric Rating Scale greater than 30, less than 65 Pain distribution between nuchal ridge and spine of the scapula Pain aggravated by local provocation maneuvers at single motion segment Antero-posterior glide Paraspinal tenderness Negative provocative maneuvers at adjacent segment Able to tolerate neck movement to 50 percent normal in all directions Exclusion Criteria: Worker's compensation or other medico-legal claim Cervical spine surgery or fracture or dislocation Uncontrolled hypertension (Blood Pressure over 140 over 90) Stroke or Transient Ischemic Attack Upper respiratory infection within 4 weeks Severe degenerative disease of the cervical spine New or significantly altered pattern of headache complaint Connective tissue disease Primary fibromyalgia Metabolic or metaplastic bone disease Whiplash injury within 12 months High cholesterol levels not well-managed medically Cardiovascular surgery in the past 6 months or planned Use of narcotic analgesic, prescription anti-inflammatory, or muscle relaxants, anti-convulsants Angina pectoris Dizziness Tinnitus Blurred vision, vertigo, undiagnosed sensory and motor disturbances Radicular symptoms and signs Current use of anticoagulant therapy Upper respiratory infection Neck pain on provocation greater than 7 out of 10 Provocation of radicular pain or sensory disturbance Hypermobility of multiple peripheral joints, Physical or mental impairment precluding following instructions or participating -in supine recumbent postures

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal manipulation<br>Participants will receive spinal manipulation delivered as segmental thrust to a specific site in the neck. They will receive three intervention sessions over 7-10 days. | Procedure: Spinal manipulation<br> <br> |
| Sham Comparator: Control manipulation<br>Participants will receive spinal manipulation delivered as non-segmental thrust to the neck. They will receive three intervention sessions over 7-10 days. | Procedure: Spinal manipulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group registration | Participants will be asked to identify which of the two interventions they feel they received. | At exit assessment following the third intervention session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity | Pain scores on the PROMIS pain severity instrument. | 1. at baseline, and 2. At exit assessment following the third intervention session | 
| Improvement | Participants will be asked to rate their level of improvement on the The Global Rating of Change instrument. | At exit assessment following the third intervention session | 
| Disability | Participants will score the The Neck Disability Index (score out of 50). | 1. at baseline, and 2. At exit assessment following the third intervention session | 
| Tenderness | Pressure algometry over a single specified spinal site will be used to measure tenderness in kg/sq.sm. | 1. at baseline, and 2. At exit assessment following the third intervention session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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manipulation, control, randomized trial, neck, pain, chronic