University of Michigan / Wayne State Chronic Pain Study

NCT ID: NCT03391661

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-10
• Study Completion Date: 2019-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Chronic Pain and the Brain

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.

Group Type: EXPERIMENTAL

Pain neuroscience education patient exercise

Intervention Type: 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

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).

Group Type: PLACEBO_COMPARATOR

Health behavior control intervention

Intervention Type: 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.

Interventions

Pain neuroscience education patient exercise

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

Health behavior control intervention

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Mark A. Lumley

Distinguished Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Kohns, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Mark A Lumley, PhD

Role: STUDY_DIRECTOR

Wayne State University

Locations

University of Michigan Physical Medicine and Rehabilitation Department

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00121358

Identifier Type: -

Identifier Source: org_study_id