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| Name | Class |
|---|---|
| St. John Providence Hospital | UNKNOWN |
| Blue Care Network of Michigan | OTHER |
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The investigators are studying whether a brief three-session mind-body workshop helps people with fibromyalgia. The investigators hypothesize that this workshop will significantly improve pain and other symptoms, compared to usual care.
The affective self-awareness approach presumes that many chronic pain states, such as fibromyalgia (FM), can be effectively treated by encouraging self-awareness of emotional tension. While anecdotally effective in selected patients, this approach has thus far not been tested in a randomized controlled trial. Our purpose is to determine whether an affective self-awareness approach significantly improves pain, tenderness, and other FM symptoms in a random sample of FM patients; and to determine what psychosocial factors predict a favorable response.
Comparisons: changes in ratings of pain, tenderness, and other symptoms between two arms of the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Workshop | Experimental | Affective Self Awareness intervention |
|
| Control | No Intervention | Waiting-list control. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Affective Self-Awareness workshop | Behavioral | Affective Self Awareness intervention: 90 minute face-to-face consultation with the treating physician, then three 2-hour weekly small-group workshops involving education regarding Mind-Body connections, written emotional expression, meditation, and self-affirmation practices. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average pain according to the Brief Pain Inventory | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Multi-dimensional Fatigue Inventory | 6 months | |
| Medical Outcomes Study sleep subscale | 6 months | |
| Perceived Stress Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael C Hsu, MD | University of Michigan Chronic Pain and Fatigue Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. John Providence Hospital | Southfield | Michigan | 48075 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20532650 | Derived | Hsu MC, Schubiner H, Lumley MA, Stracks JS, Clauw DJ, Williams DA. Sustained pain reduction through affective self-awareness in fibromyalgia: a randomized controlled trial. J Gen Intern Med. 2010 Oct;25(10):1064-70. doi: 10.1007/s11606-010-1418-6. Epub 2010 Jun 8. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| D005221 | Fatigue |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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|
| 6 months |
| SF-36 Physical Functional Status | 6 months |
| Profile of Mood States | 6 months |
| Tender point count | 6 months |
| Dolorimeter tender point score | 6 months |
| Ascending and Multiple Random Staircase thumbnail sensitivity thresholds | 6 months |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |