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

NCT ID: NCT03509649

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-05-17

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.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experienced - Positive

Participants will receive cervical spine manipulation after being given a positive description of the technique from an experienced clinician

Group Type: EXPERIMENTAL

Cervical spine manipulation

Intervention Type: PROCEDURE

High-velocity low-amplitude thrust joint manipulation to the cervical spine

Experienced - Negative

Participants will receive cervical spine manipulation after being given a negative description of the technique from an experienced clinician

Group Type: EXPERIMENTAL

Cervical spine manipulation

Intervention Type: PROCEDURE

High-velocity low-amplitude thrust joint manipulation to the cervical spine

Novice - Positive

Participants will receive cervical spine manipulation after being given a positive description of the technique from a novice clinician

Group Type: ACTIVE_COMPARATOR

Cervical spine manipulation

Intervention Type: PROCEDURE

High-velocity low-amplitude thrust joint manipulation to the cervical spine

Novice - Negative

Participants will receive cervical spine manipulation after being given a negative description of the technique from a novice clinician

Group Type: ACTIVE_COMPARATOR

Cervical spine manipulation

Intervention Type: PROCEDURE

High-velocity low-amplitude thrust joint manipulation to the cervical spine

Interventions

Cervical spine manipulation

High-velocity low-amplitude thrust joint manipulation to the cervical spine

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nevada, Las Vegas

OTHER

Sponsor Role: lead

Responsible Party

Emilio J Puentedura, PT, DPT, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emilio J Puentedura, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor University

Locations

University of Nevada Las Vegas - Department of Physical Therapy

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

1144771

Identifier Type: -

Identifier Source: org_study_id