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University of Michigan / Wayne State Chronic Pain Study

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ClinicalTrials.gov Identifier: NCT03391661
Recruitment Status : Active, not recruiting
First Posted : January 5, 2018
Last Update Posted : October 3, 2018
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Mark A. Lumley, Wayne State University

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.


Condition or disease Intervention/treatment Phase
Chronic Musculoskeletal Pain Behavioral: Pain neuroscience education patient exercise Behavioral: Health behavior control intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Openness to Cognitive Approach of Nonspecific Chronic Pain
Actual Study Start Date : December 10, 2017
Actual Primary Completion Date : May 17, 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Chronic Pain and the Brain
This condition is a 10-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.
Behavioral: Pain neuroscience education patient exercise
Patients complete a 10-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.

Placebo Comparator: Health Behavior Control
This 10-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).
Behavioral: Health behavior control intervention
Patients engage in a 10-minute on-line exercise examining their health behaviors in five domains: exercise, sleep, diet, hygiene, and social connections




Primary Outcome Measures :
  1. Brief Pain Inventory [ Time Frame: Change from baseline to 1-Month follow-up (with plan for secondary 10-month follow-up) ]
    Self-reported pain and dysfunction


Secondary Outcome Measures :
  1. Survey of Pain Attitudes [ Time Frame: Change from baseline to 1-Month follow-up ]
    Patient's attitudes about pain control, solicitude, medication, pain-related disability, pain and emotions, medical cures for pain, and pain-related harm

  2. Pain Stages of Change Questionnaire [ Time Frame: Change from baseline to 1-Month follow-up ]
    Readiness to engage in pain self-management (stages of pre-contemplation, contemplation, preparation, action)

  3. Pain Catastrophizing Scale [ Time Frame: Change from baseline to 1-Month follow-up ]
    Pain-related rumination, helplessness, and magnification

  4. Pain Disability Index [ Time Frame: Change from baseline to 1-Month follow-up ]
    Pain-related disability

  5. Tampa Scale for Kinesiophobia [ Time Frame: Change from baseline to 1-Month follow-up ]
    Fear of movement

  6. Patient Self-report Survey for the Assessment of Fibromyalgia [ Time Frame: Change from baseline to 1-Month follow-up ]
    Overall fibromyalgia symptoms

  7. Patient-Reported Outcomes Measurement Information System: Anger short form 5a [ Time Frame: Change from baseline to 1-Month follow-up ]
    Self-reported anger

  8. Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a [ Time Frame: Change from baseline to 1-Month follow-up ]
    Self-reported anxiety

  9. Patient-Reported Outcomes Measurement Information System: Depression short form 8b [ Time Frame: Change from baseline to 1-Month follow-up ]
    Self-reported depression

  10. Satisfaction with Life Scale [ Time Frame: Change from baseline to 1-Month follow-up ]
    Self-reported life satisfaction



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391661


Locations
United States, Michigan
University of Michigan Physical Medicine and Rehabilitation Department
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Wayne State University
University of Michigan
Investigators
Principal Investigator: David Kohns, MD University of Michigan
Study Director: Mark A Lumley, PhD Wayne State University

Responsible Party: Mark A. Lumley, Distinguished Professor of Psychology, Wayne State University
ClinicalTrials.gov Identifier: NCT03391661     History of Changes
Other Study ID Numbers: HUM00121358
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chronic Pain
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases