University of Michigan / Wayne State Chronic Pain Study

Wayne State University

Status: Completed

Conditions: Chronic Musculoskeletal Pain

Treatments: Behavioral: Pain neuroscience education patient exercise; Behavioral: Health behavior control intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03391661

HUM00121358

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 2 patient groups, including a placebo group

Chronic Pain and the Brain

Experimental group

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.

Treatment:

Behavioral: Pain neuroscience education patient exercise

Health Behavior Control

Placebo Comparator group

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).

Treatment:

Behavioral: Health behavior control intervention