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Fibromyalgia is a medical condition characterized by musculoskeletal pain, fatigue, sleep disturbances and depression. It affects population at a socioeconomically active age and represents a burden for the patients and the health care system due to its personal and functional implications. At this moment, there is no completely effective treatment for fibromyalgia, and acupuncture has been a promising alternative. This trial aims to evaluate if addition of acupuncture to standard care represents an improvement in comparison with standard care only. Thus, patients enrolled in this trial will be randomly allocated into one of two groups: group A, who besides standard treatment will receive 12 sessions of acupuncture; and group B, who will receive standard care with monthly orientation sessions for the same period. Patients will be evaluated at baseline, after completion of acupuncture treatment or orientation, and after an additional 12-week follow up. Evaluation will be based on diaries of pain and medication, and standard scales of pain, quality of life and disability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | Patients will receive acupuncture treatment in addition to standard care, coming to twelve weekly acupuncture sessions |
|
| Orientation | Active Comparator | Patients will receive standard care only, coming to three monthly orientation sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Needling of acupoints, some of them receiving electrostimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Fibromyalgia Impact Questionnaire (FIQ) score | Twelve weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly Likert scale in pain diary | Twelve weeks from baseline | |
| Visual Analog Scale (VAS) for pain | Twelve weeks from baseline | |
| Short Form 36 (SF-36) score for quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fernando P de Farias, MD, PhD | Contact | (+5521) 9263-8673 | fernandopfarias@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fernando P de Farias, MD, PhD | Santa Casa da Misericordia do Rio de Janeiro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Casa da Misericordia do Rio de Janeiro Hospital; Instituto de Acupuntura do Rio de Janeiro | Recruiting | Rio de Janeiro | Rio de Janeiro | Brazil |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Orientation |
| Behavioral |
Orientation sessions focusing in fibromyalgia |
|
| Twelve weeks from baseline |
| Health Assessment Questionnaire - Disability Index (HAQ-DI) score | Twelve weeks from baseline |
| Hospital Anxiety and Depression (HAD) Scale | Twelve weeks from baseline |
| Fibromyalgia Impact Questionnaire (FIQ) score | Twenty-four weeks from baseline |
| Weekly Likert scale in pain diary | Twenty-four weeks from baseline |
| Visual Analog Scale (VAS) for pain | Twenty-four weeks from baseline |
| Short Form 36 (SF-36) score for quality of life | Twenty-four weeks from baseline |
| Health Assessment Questionnaire - Disability Index (HAQ-DI) score | Twenty-four weeks from baseline |
| Hospital Anxiety and Depression (HAD) Scale | Twenty-four weeks from baseline |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |