University of Michigan / Wayne State Chronic Pain Study
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|ClinicalTrials.gov Identifier: NCT03391661|
Recruitment Status : Active, not recruiting
First Posted : January 5, 2018
Last Update Posted : October 3, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Musculoskeletal Pain||Behavioral: Pain neuroscience education patient exercise Behavioral: Health behavior control intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Openness to Cognitive Approach of Nonspecific Chronic Pain|
|Actual Study Start Date :||December 10, 2017|
|Actual Primary Completion Date :||May 17, 2018|
|Estimated Study Completion Date :||June 2019|
Experimental: Chronic Pain and the Brain
This condition is a 10-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
Patients complete a 10-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.
Placebo Comparator: Health Behavior Control
This 10-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
Patients engage in a 10-minute on-line exercise examining their health behaviors in five domains: exercise, sleep, diet, hygiene, and social connections
- Brief Pain Inventory [ Time Frame: Change from baseline to 1-Month follow-up (with plan for secondary 10-month follow-up) ]Self-reported pain and dysfunction
- Survey of Pain Attitudes [ Time Frame: Change from baseline to 1-Month follow-up ]Patient's attitudes about pain control, solicitude, medication, pain-related disability, pain and emotions, medical cures for pain, and pain-related harm
- Pain Stages of Change Questionnaire [ Time Frame: Change from baseline to 1-Month follow-up ]Readiness to engage in pain self-management (stages of pre-contemplation, contemplation, preparation, action)
- Pain Catastrophizing Scale [ Time Frame: Change from baseline to 1-Month follow-up ]Pain-related rumination, helplessness, and magnification
- Pain Disability Index [ Time Frame: Change from baseline to 1-Month follow-up ]Pain-related disability
- Tampa Scale for Kinesiophobia [ Time Frame: Change from baseline to 1-Month follow-up ]Fear of movement
- Patient Self-report Survey for the Assessment of Fibromyalgia [ Time Frame: Change from baseline to 1-Month follow-up ]Overall fibromyalgia symptoms
- Patient-Reported Outcomes Measurement Information System: Anger short form 5a [ Time Frame: Change from baseline to 1-Month follow-up ]Self-reported anger
- Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a [ Time Frame: Change from baseline to 1-Month follow-up ]Self-reported anxiety
- Patient-Reported Outcomes Measurement Information System: Depression short form 8b [ Time Frame: Change from baseline to 1-Month follow-up ]Self-reported depression
- Satisfaction with Life Scale [ Time Frame: Change from baseline to 1-Month follow-up ]Self-reported life satisfaction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391661
|United States, Michigan|
|University of Michigan Physical Medicine and Rehabilitation Department|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||David Kohns, MD||University of Michigan|
|Study Director:||Mark A Lumley, PhD||Wayne State University|