Impact of Practitioner and Instructional Set on Subject Perceptions and Expectations of Cervical Spine Manipulation

Study Overview
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Brief Summary
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Determine effects of perceptions and expectations on experience of cervical spine manipulation

Detailed Description
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The purpose of this study is to better understand how therapists may affect a patient's thoughts/ beliefs/ opinions on cervical spine (neck) manipulation. Current evidence suggests that patients who have a positive expectation about neck manipulation are more likely to report benefit from it, and we wish to determine if the perceived experience level of the therapist and the words they use to describe neck manipulation will affect the patient's perception.

Official Title
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The Impact of Practitioner and Instructional Set on Subject Expectations of Cervical Spine Manipulation

Conditions
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Neck Pain

Intervention / Treatment
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* Procedure: Cervical spine manipulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-65 years; must report having no current episode of mechanical neck pain; must be willing to participate; must indicate they have not had their neck manipulated by a physical therapist, osteopath or chiropractor within the last 5 years. Exclusion Criteria: 'Red flag' items indicated in your Neck Medical Screening Questionnaire such as: history of a tumor, bone fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, heart disease, and stroke. History of neck whiplash injury. Diagnosis from your physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) in both arms. Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands or face, muscle wasting in the hands, altered taste, and presence of abnormal reflexes. Evidence of neurological signs suggesting nerve root entrapment (pinched nerve in the neck). Prior surgery to your neck or upper back. A medical condition which may change your sensation of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency). Diagnosis from your physician of fibromyalgia syndrome. Currently pregnant, or think you may be pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experienced - Positive<br>Participants will receive cervical spine manipulation after being given a positive description of the technique from an experienced clinician | Procedure: Cervical spine manipulation<br>* High-velocity low-amplitude thrust joint manipulation to the cervical spine<br>|
| Experimental: Experienced - Negative<br>Participants will receive cervical spine manipulation after being given a negative description of the technique from an experienced clinician | Procedure: Cervical spine manipulation<br>* High-velocity low-amplitude thrust joint manipulation to the cervical spine<br>|
| Active Comparator: Novice - Positive<br>Participants will receive cervical spine manipulation after being given a positive description of the technique from a novice clinician | Procedure: Cervical spine manipulation<br>* High-velocity low-amplitude thrust joint manipulation to the cervical spine<br>|
| Active Comparator: Novice - Negative<br>Participants will receive cervical spine manipulation after being given a negative description of the technique from a novice clinician | Procedure: Cervical spine manipulation<br>* High-velocity low-amplitude thrust joint manipulation to the cervical spine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Perceived Effect Scale (GPE) | 7 point Likert scale anchored with 1 completely recovered to 7 worse than ever. | Immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of comfort scale | 5 point Likert scale ranging from 1 very comfortable to 5 very uncomfortable | Immediate | 
| Beliefs about cervical spine manipulation | 6 questions determining participant's beliefs about safety, comfort and effectiveness of spinal manipulation. Likert scale with statements participants can 'completely disagree', 'somewhat disagree', 'neutral', 'somewhat agree', or 'completely agree' with | Immediate |