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

Primary Purpose

Neck Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cervical spine manipulation
Sponsored by
University of Nevada, Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Nevada Las Vegas - Department of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Experienced - Positive

Experienced - Negative

Novice - Positive

Novice - Negative

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Global Perceived Effect Scale (GPE)
7 point Likert scale anchored with "1" completely recovered to "7" worse than ever.

Secondary Outcome Measures

Perception of comfort scale
5 point Likert scale ranging from 1 "very comfortable" to 5 "very uncomfortable
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

Full Information

First Posted
April 9, 2018
Last Updated
April 16, 2019
Sponsor
University of Nevada, Las Vegas
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1. Study Identification

Unique Protocol Identification Number
NCT03509649
Brief Title
Impact of Practitioner and Instructional Set on Subject Perceptions and Expectations of Cervical Spine Manipulation
Official Title
The Impact of Practitioner and Instructional Set on Subject Expectations of Cervical Spine Manipulation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
May 17, 2019 (Anticipated)
Study Completion Date
May 17, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experienced - Positive
Arm Type
Experimental
Arm Description
Participants will receive cervical spine manipulation after being given a positive description of the technique from an experienced clinician
Arm Title
Experienced - Negative
Arm Type
Experimental
Arm Description
Participants will receive cervical spine manipulation after being given a negative description of the technique from an experienced clinician
Arm Title
Novice - Positive
Arm Type
Active Comparator
Arm Description
Participants will receive cervical spine manipulation after being given a positive description of the technique from a novice clinician
Arm Title
Novice - Negative
Arm Type
Active Comparator
Arm Description
Participants will receive cervical spine manipulation after being given a negative description of the technique from a novice clinician
Intervention Type
Procedure
Intervention Name(s)
Cervical spine manipulation
Intervention Description
High-velocity low-amplitude thrust joint manipulation to the cervical spine
Primary Outcome Measure Information:
Title
Global Perceived Effect Scale (GPE)
Description
7 point Likert scale anchored with "1" completely recovered to "7" worse than ever.
Time Frame
Immediate
Secondary Outcome Measure Information:
Title
Perception of comfort scale
Description
5 point Likert scale ranging from 1 "very comfortable" to 5 "very uncomfortable
Time Frame
Immediate
Title
Beliefs about cervical spine manipulation
Description
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
Time Frame
Immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilio J Puentedura, DPT, PhD
Organizational Affiliation
Baylor University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nevada Las Vegas - Department of Physical Therapy
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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