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

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

Determine effects of perceptions and expectations on experience of cervical spine manipulation

Study Overview

• Status: Unknown
• Conditions: Neck Pain
• Intervention / Treatment: Procedure: 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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89154
      • University of Nevada Las Vegas - Department of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age 18-65 years;
2. must report having no current episode of mechanical neck pain;
3. must be willing to participate;
4. must indicate they have not had their neck manipulated by a physical therapist, osteopath or chiropractor within the last 5 years.

Exclusion Criteria:

1. '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.
2. History of neck whiplash injury.
3. Diagnosis from your physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) in both arms.
4. 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.
5. Evidence of neurological signs suggesting nerve root entrapment (pinched nerve in the neck).
6. Prior surgery to your neck or upper back.
7. 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).
8. Diagnosis from your physician of fibromyalgia syndrome.
9. Currently pregnant, or think you may be pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Nevada, Las Vegas
• Investigators: Principal Investigator: Emilio J Puentedura, DPT, PhD, Baylor University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): May 17, 2019
• Study Completion (Anticipated): May 17, 2019

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 1144771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No