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

NCT03509649 | Unknown

• 1 other identifier: 1144771
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

• Global Perceived Effect Scale (GPE)

  7 point Likert scale anchored with "1" completely recovered to "7" worse than ever.

  Immediate

Secondary Outcomes (2)

• Perception of comfort scale

  Immediate

• Beliefs about cervical spine manipulation

  Immediate

Study Arms (4)

Experienced - Positive

EXPERIMENTAL

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

Procedure: Cervical spine manipulation

Experienced - Negative

EXPERIMENTAL

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

Procedure: Cervical spine manipulation

Novice - Positive

ACTIVE COMPARATOR

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

Procedure: Cervical spine manipulation

Novice - Negative

ACTIVE COMPARATOR

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

Procedure: Cervical spine manipulation

Interventions

Cervical spine manipulation PROCEDURE

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

Experienced - Negative; Experienced - Positive; Novice - Negative; Novice - Positive

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• '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.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

University of Nevada Las Vegas - Department of Physical Therapy

Las Vegas, Nevada, 89154, United States

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emilio J Puentedura, DPT, PhD

  Baylor University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants randomly assigned to one of 2 instructional sets (positive/ negative) and randomly assigned to one of 2 practitioner experience levels (experienced/ novice)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 26, 2018
• Study Start: April 1, 2018
• Primary Completion: May 17, 2019
• Study Completion: May 17, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)