The Impact of Practitioner and Instructional Set on Subject Expectations of Cervical Spine Manipulation
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Global Perceived Effect Scale (GPE)
Study Overview
Brief Summary
Determine effects of perceptions and expectations on experience of cervical spine manipulation
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Participants randomly assigned to one of 2 instructional sets (positive/ negative) and randomly assigned to one of 2 practitioner experience levels (experienced/ novice)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Experienced - Positive
Participants will receive cervical spine manipulation after being given a positive description of the technique from an experienced clinician
Intervention: Cervical spine manipulation (Procedure)
Experienced - Negative
Participants will receive cervical spine manipulation after being given a negative description of the technique from an experienced clinician
Intervention: Cervical spine manipulation (Procedure)
Novice - Positive
Participants will receive cervical spine manipulation after being given a positive description of the technique from a novice clinician
Intervention: Cervical spine manipulation (Procedure)
Novice - Negative
Participants will receive cervical spine manipulation after being given a negative description of the technique from a novice clinician
Intervention: Cervical spine manipulation (Procedure)
Outcomes
Primary Outcomes
Global Perceived Effect Scale (GPE)
Time Frame: Immediate
7 point Likert scale anchored with "1" completely recovered to "7" worse than ever.
Secondary Outcomes
- Perception of comfort scale(Immediate)
- Beliefs about cervical spine manipulation(Immediate)
Investigators
Emilio J Puentedura, PT, DPT, PhD
Principal Investigator
University of Nevada, Las Vegas