University of Michigan / Wayne State Chronic Pain Study

NCT03391661 | Completed

• 1 other identifier: HUM00121358
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory

  Self-reported pain and dysfunction

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

Secondary Outcomes (8)

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

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

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

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

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

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

• Pain attributions questionnaires

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

• Pain Stages of Change Questionnaire

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

Study Arms (2)

Chronic Pain and the Brain

EXPERIMENTAL

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.

Behavioral: Pain neuroscience education patient exercise

Health Behavior Control

PLACEBO COMPARATOR

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).

Behavioral: Health behavior control intervention

Interventions

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.

Chronic Pain and the Brain

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.

Health Behavior Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wayne State University: lead
• University of Michigan: collaborator

Study Sites (1)

University of Michigan Physical Medicine and Rehabilitation Department

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• David Kohns, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Mark A Lumley, PhD

  Wayne State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Psychology

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 5, 2018
• Study Start: December 10, 2017
• Primary Completion: May 17, 2018
• Study Completion: February 28, 2019
• Last Updated: July 25, 2019

Record last verified: 2019-07

Locations

US (1)