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OpenTrials
Completed

NCT Number: NCT03391661

University of Michigan / Wayne State Chronic Pain Study

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.

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Key information

Conditions

Chronic Musculoskeletal Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Physical Medicine and Rehabilitation Department

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain neuroscience education patient exercise

Behavioral

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.

Health behavior control intervention

Behavioral

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 outcomes

  1. Brief Pain Inventory

    Time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)

    Self-reported pain and dysfunction

Secondary outcomes

  1. Patient-Reported Outcomes Measurement Information System: Depression short form 8b

    Time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)

    Self-reported depression

  2. Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a

    Time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)

    Self-reported anxiety

  3. Patient-Reported Outcomes Measurement Information System: Anger short form 5a

    Time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)

    Self-reported anger

  4. Pain attributions questionnaires

    Time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)

    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])

  5. Pain Stages of Change Questionnaire

    Time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)

    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.

  6. Pain Catastrophizing Scale

    Time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)

    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)

  7. Tampa Scale for Kinesiophobia

    Time frame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)

    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)

  8. Satisfaction with Life Scale

    Time frame: Change from baseline to 1-month follow-up (with secondary 10-month follow-up)

    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)

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Collaborators

  • University of Michigan

Registry information

Official study title

Openness to Cognitive Approach of Nonspecific Chronic Pain

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 5, 2018
Registry last updated
Jul 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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