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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03509649
• Other study ID #: 1144771
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: May 17, 2019

Study information

• Verified date: April 2019
• Source: University of Nevada, Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: May 17, 2019
• Est. primary completion date: May 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain

Intervention

Procedure:
• Cervical spine manipulation
High-velocity low-amplitude thrust joint manipulation to the cervical spine

Locations

Country	Name	City	State
United States	University of Nevada Las Vegas - Department of Physical Therapy	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Perceived Effect Scale (GPE)	7 point Likert scale anchored with "1" completely recovered to "7" worse than ever.	Immediate
Secondary	Perception of comfort scale	5 point Likert scale ranging from 1 "very comfortable" to 5 "very uncomfortable	Immediate
Secondary	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