Clinical trial NCT03391661: University of Michigan / Wayne State Chronic Pain Study
Official title: Openness to Cognitive Approach of Nonspecific Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2018-01-05
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Brief Pain Inventory
timeFrame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System: Depression short form 8b
timeFrame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
measure: Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a
timeFrame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
measure: Patient-Reported Outcomes Measurement Information System: Anger short form 5a
timeFrame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
measure: Pain attributions questionnaires
timeFrame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
measure: Pain Stages of Change Questionnaire
timeFrame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
measure: Pain Catastrophizing Scale
timeFrame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
measure: Tampa Scale for Kinesiophobia
timeFrame: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
measure: Satisfaction with Life Scale
timeFrame: Change from baseline to 1-month follow-up (with secondary 10-month follow-up)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Physical Medicine and Rehabilitation Department
state: Michigan
Study officials:
affiliation: University of Michigan
name: David Kohns, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Mark A Lumley, PhD
role: STUDY_DIRECTOR
References: