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| Name | Class |
|---|---|
| University of Michigan | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory | Self-reported pain and dysfunction | Change from baseline to 1-Month follow-up (with secondary 10-month follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System: Depression short form 8b | Self-reported depression | Change from baseline to 1-Month follow-up (with secondary 10-month follow-up) |
| Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Kohns, MD | University of Michigan | Principal Investigator |
| Mark A Lumley, PhD | Wayne State University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Physical Medicine and Rehabilitation Department | Ann Arbor | Michigan | 48109 | United States |
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| 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. |
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Self-reported anxiety |
| Change from baseline to 1-Month follow-up (with secondary 10-month follow-up) |
| Patient-Reported Outcomes Measurement Information System: Anger short form 5a | Self-reported anger | Change from baseline to 1-Month follow-up (with secondary 10-month follow-up) |
| Pain attributions questionnaires | Two self-report questionnaires were developed to assess psychological and brain influences on pain. The 4-item psychological attribution scale assesses patients' beliefs that their thoughts and feelings and psychological therapy impacts pain, and the 3-item brain attribution scale assesses patient's beliefs that their pain is brain-based. Mean scores will be computed for both scales separately (0-4; higher scores indicating greater belief that pain is a brain-related [brain attribution] construct and that pain is affected by thoughts, feelings, and psychological interventions [psychological attribution]) | Change from baseline to 1-Month follow-up (with secondary 10-month follow-up) |
| Pain Stages of Change Questionnaire | The Pain Stages of Change questionnaire (Kerns, Rosenberg, Jamison, Caudill, & Haythornthwaite, 1997): an overall readiness score will be calculated using mean scores of the four subscales. Readiness is the sum of patient mean ratings for contemplation (C; 1-5), action (A; 1-5), and maintenance (M; 1-5), minus the mean score for precontemplation (PC; 1-5): C + A + M - PC = Readiness. Higher scores indicate greater readiness. | Change from baseline to 1-Month follow-up (with secondary 10-month follow-up) |
| Pain Catastrophizing Scale | Pain Catastrophizing Scale (Sullivan et al., 1995): A summed score of the 13 catastrophizing items will be computed (0-52, higher scores indicate greater catastrophizing) | Change from baseline to 1-Month follow-up (with secondary 10-month follow-up) |
| Tampa Scale for Kinesiophobia | The Tampa Kinesiophobia Scale (Miller, Kori, &Todd, 1991): A mean score of the 11 items will be computed (1-4, higher scores indicating greater kinesiophobia) | Change from baseline to 1-Month follow-up (with secondary 10-month follow-up) |
| Satisfaction with Life Scale | The Satisfaction with Life Scale (Emmons, Larsen, & Griffin, 1985): A mean score of the 5 items will be computed (1-7, higher scores indicating greater life satisfaction) | Change from baseline to 1-month follow-up (with secondary 10-month follow-up) |