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This study is an acceptability and feasibility study of two adjunctive interventions: group education with stretching; and group acupuncture. The study population will be women with primary fibromyalgia who have not previously used acupuncture in the last 3 months. Both interventions will be 10 weeks in length and will be conducted at the Oregon Health & Science University. The primary hypothesis is that both arms will be acceptable and feasible in the study population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Education with Stretching | Active Comparator | Group Education with Stretching will receive 10 small group educational classes at the Oregon Health & Science University (OHSU), based on the book "Fibromyalgia (Biographies of Disease)." Each chapter of Fibromyalgia covers different aspects of the disease and its treatment including global, economic, and risk statistics; a timeline of key events in the study of fibromyalgia; common symptoms and diagnostic indicators; natural history of fibromyalgia; pharmacologic and non-pharmacologic treatments; associated disorders and syndromes; and impact of fibromyalgia at home, in the workplace and in society at large. Participants will be informed that they should not start additional treatments until the end of the study and complementary and alternative treatments won't be covered until the last session. Participants will also receive a digital video disk (DVD) covering stretching appropriate for fibromyalgia patients and will be asked to incorporate the DVD over the next 10 weeks. |
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| Group Acupuncture | Experimental | 20 treatments in 10 weeks will include individualized acupuncture in a group setting, dietary and lifestyle recommendations each based on the Traditional Chinese Medicine diagnosis (zhang fu) at the time of the visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Education and Stretching | Behavioral |
| ||
| Group Acupuncture |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Participation Rate | Rates of treatment attendance in both arms | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Drop out rate | Drop out rates in both arms at weeks 10 and 14 | 10 and 14 weeks |
| Completion of Evaluation Rates | Completion rates of questionnaires and examinations in both arms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott D Mist, PhD, MAcOM | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Procedure |
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| Weeks 0, 5, 10 and 14 |
| Fibromyalgia Impact Questionnaire Revised | Comparing overall score of the Fibromyalgia Impact Questionnaire - Revised between the two arms over time. | Weeks 0, 5, 10, and 14 |
| Nociceptive Reflex Testing | Nociceptive Reflex will be tested at weeks 0, 5, 10 and 14. Changes in nociceptive reflex will be compared within individuals and between arms. | Weeks 0, 5, 10 and 14 |
| Sleep Quality and Daily Activity | Sleep quality and daily activity will be measured using Actiwatch. Changes will be explored within individuals and between groups. | Weeks 0, 5, 10, and 14 |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |