Back to resultsUniversity of Michigan / Wayne State Chronic Pain Study
Primary Purpose
Chronic Musculoskeletal Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain neuroscience education patient exercise
Health behavior control intervention
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Musculoskeletal Pain
Eligibility Criteria
Inclusion Criteria:
- English-speaking adults ages 18 years or older with internet access who are referred to the University of Michigan Health Service Physical Medicine and Rehabilitation Spine Program identified the physician with chronic nonspecific back pain (longer than 3 months) or fibromyalgia. Degenerative changes seen on imaging are considered nonspecific. Alternatively, enrolled in the University of Michigan Health Research Volunteer Pool with a profile that includes chronic low back pain or fibromyalgia.
Exclusion Criteria:
- Any signs of a serious underlying condition (cancer, infection, cauda equine), spinal stenosis or radiculopathy, or other specific spinal cause (vertebral compression fracture or ankylosing spondylitis). Those patients who are being considered for an interventional spine procedures or surgical consults would not be included in this study.
- Individuals receiving or applying for compensation or disability, the inability to provide written informed consent, severe physical impairment (e.g. blindness, deafness), co-morbid medical condition limiting function (e.g. malignant cancer), the use of illicit drug use, or a psychiatric condition that would limit judgment.
Sites / Locations
- University of Michigan Physical Medicine and Rehabilitation Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Chronic Pain and the Brain
Health Behavior Control
Arm Description
This condition is a 15 to 20-minute exercise that patients complete in which they examine variables in themselves that suggest that their pain is driven by central nervous system processes / their brains.
This 15 to 20-minute exercise is designed as a control condition that has face validity as helpful and that relates to health. Thus, patients are asked to examine various domains of their own health behavior as engaged in over the past 24 hours (e.g., nutrition, sleep, exercise, hygiene, social connections).
Outcomes
Primary Outcome Measures
Brief Pain Inventory
Self-reported pain and dysfunction
Secondary Outcome Measures
Patient-Reported Outcomes Measurement Information System: Depression short form 8b
Self-reported depression
Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a
Self-reported anxiety
Patient-Reported Outcomes Measurement Information System: Anger short form 5a
Self-reported anger
Pain attributions questionnaires
Two self-report questionnaires were developed to assess psychological and brain influences on pain. The 4-item psychological attribution scale assesses patients' beliefs that their thoughts and feelings and psychological therapy impacts pain, and the 3-item brain attribution scale assesses patient's beliefs that their pain is brain-based. Mean scores will be computed for both scales separately (0-4; higher scores indicating greater belief that pain is a brain-related [brain attribution] construct and that pain is affected by thoughts, feelings, and psychological interventions [psychological attribution])
Pain Stages of Change Questionnaire
The Pain Stages of Change questionnaire (Kerns, Rosenberg, Jamison, Caudill, & Haythornthwaite, 1997): an overall readiness score will be calculated using mean scores of the four subscales. Readiness is the sum of patient mean ratings for contemplation (C; 1-5), action (A; 1-5), and maintenance (M; 1-5), minus the mean score for precontemplation (PC; 1-5): C + A + M - PC = Readiness. Higher scores indicate greater readiness.
Pain Catastrophizing Scale
Pain Catastrophizing Scale (Sullivan et al., 1995): A summed score of the 13 catastrophizing items will be computed (0-52, higher scores indicate greater catastrophizing)
Tampa Scale for Kinesiophobia
The Tampa Kinesiophobia Scale (Miller, Kori, &Todd, 1991): A mean score of the 11 items will be computed (1-4, higher scores indicating greater kinesiophobia)
Satisfaction with Life Scale
The Satisfaction with Life Scale (Emmons, Larsen, & Griffin, 1985): A mean score of the 5 items will be computed (1-7, higher scores indicating greater life satisfaction)
Full Information
NCT ID
NCT03391661
First Posted
December 22, 2017
Last Updated
July 23, 2019
Sponsor
Wayne State University
Collaborators
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT03391661
Brief Title
University of Michigan / Wayne State Chronic Pain Study
Official Title
Openness to Cognitive Approach of Nonspecific Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 10, 2017 (Actual)
Primary Completion Date
May 17, 2018 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is designed to determine if a brief educational program can alter the attitudes and knowledge of individuals with chronic back pain, which is likely to be non-structural in nature.
Individuals will be randomly assigned to an experimental condition (performs written educational and emotional awareness exercises) or a control condition (completes a general health activities questionnaire). Comparisons will be made to assess the degree of centralized pain features and functional improvements at 1-month follow-up. A 10-month follow-up as a secondary endpoint is also planned.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Musculoskeletal Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chronic Pain and the Brain
Arm Type
Experimental
Arm Description
This condition is a 15 to 20-minute exercise that patients complete in which they examine variables in themselves that suggest that their pain is driven by central nervous system processes / their brains.
Arm Title
Health Behavior Control
Arm Type
Placebo Comparator
Arm Description
This 15 to 20-minute exercise is designed as a control condition that has face validity as helpful and that relates to health. Thus, patients are asked to examine various domains of their own health behavior as engaged in over the past 24 hours (e.g., nutrition, sleep, exercise, hygiene, social connections).
Intervention Type
Behavioral
Intervention Name(s)
Pain neuroscience education patient exercise
Intervention Description
Patients complete a 15 to 20-minute on-line exercise that inquires about 5 domains: the degree of central sensitization symptoms, catastrophizing and kinesiophobia, personality factors, stressors that triggered or exacerbated the pain, and adverse childhood experiences.
Intervention Type
Behavioral
Intervention Name(s)
Health behavior control intervention
Intervention Description
Patients engage in a 15 to 20-minute on-line exercise examining their health behaviors in five domains: exercise, sleep, diet, hygiene, and social connections.
Primary Outcome Measure Information:
Title
Brief Pain Inventory
Description
Self-reported pain and dysfunction
Time Frame
Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System: Depression short form 8b
Description
Self-reported depression
Time Frame
Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Title
Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a
Description
Self-reported anxiety
Time Frame
Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Title
Patient-Reported Outcomes Measurement Information System: Anger short form 5a
Description
Self-reported anger
Time Frame
Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Title
Pain attributions questionnaires
Description
Two self-report questionnaires were developed to assess psychological and brain influences on pain. The 4-item psychological attribution scale assesses patients' beliefs that their thoughts and feelings and psychological therapy impacts pain, and the 3-item brain attribution scale assesses patient's beliefs that their pain is brain-based. Mean scores will be computed for both scales separately (0-4; higher scores indicating greater belief that pain is a brain-related [brain attribution] construct and that pain is affected by thoughts, feelings, and psychological interventions [psychological attribution])
Time Frame
Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Title
Pain Stages of Change Questionnaire
Description
The Pain Stages of Change questionnaire (Kerns, Rosenberg, Jamison, Caudill, & Haythornthwaite, 1997): an overall readiness score will be calculated using mean scores of the four subscales. Readiness is the sum of patient mean ratings for contemplation (C; 1-5), action (A; 1-5), and maintenance (M; 1-5), minus the mean score for precontemplation (PC; 1-5): C + A + M - PC = Readiness. Higher scores indicate greater readiness.
Time Frame
Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Title
Pain Catastrophizing Scale
Description
Pain Catastrophizing Scale (Sullivan et al., 1995): A summed score of the 13 catastrophizing items will be computed (0-52, higher scores indicate greater catastrophizing)
Time Frame
Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Title
Tampa Scale for Kinesiophobia
Description
The Tampa Kinesiophobia Scale (Miller, Kori, &Todd, 1991): A mean score of the 11 items will be computed (1-4, higher scores indicating greater kinesiophobia)
Time Frame
Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Title
Satisfaction with Life Scale
Description
The Satisfaction with Life Scale (Emmons, Larsen, & Griffin, 1985): A mean score of the 5 items will be computed (1-7, higher scores indicating greater life satisfaction)
Time Frame
Change from baseline to 1-month follow-up (with secondary 10-month follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English-speaking adults ages 18 years or older with internet access who are referred to the University of Michigan Health Service Physical Medicine and Rehabilitation Spine Program identified the physician with chronic nonspecific back pain (longer than 3 months) or fibromyalgia. Degenerative changes seen on imaging are considered nonspecific. Alternatively, enrolled in the University of Michigan Health Research Volunteer Pool with a profile that includes chronic low back pain or fibromyalgia.
Exclusion Criteria:
Any signs of a serious underlying condition (cancer, infection, cauda equine), spinal stenosis or radiculopathy, or other specific spinal cause (vertebral compression fracture or ankylosing spondylitis). Those patients who are being considered for an interventional spine procedures or surgical consults would not be included in this study.
Individuals receiving or applying for compensation or disability, the inability to provide written informed consent, severe physical impairment (e.g. blindness, deafness), co-morbid medical condition limiting function (e.g. malignant cancer), the use of illicit drug use, or a psychiatric condition that would limit judgment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kohns, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark A Lumley, PhD
Organizational Affiliation
Wayne State University
Official's Role
Study Director
Facility Information:
Facility Name
University of Michigan Physical Medicine and Rehabilitation Department
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
University of Michigan / Wayne State Chronic Pain Study
We'll reach out to this number within 24 hrs