NCT02053090已完成不适用
Complementary and Alternative Medicine (CAM) for Fibromyalgia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 431
- 试验地点
- 2
- 主要终点
- Treatment Participation Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having met American College of Rheumatology (1990) criteria for the diagnosis of fibromyalgia
- •Having a primary Traditional Chinese Medicine (TCM) diagnosis of either Liver Qi Stagnation, Qi and Blood Stagnation, or Qi and Blood Deficiency
- •Female gender
- •Reported average pain of 5 or higher over last week on a scale of 0 to 10 with ten indicating higher pain.
- •Willingness to limit the introduction or change of any medications or treatment modalities for control of fibromyalgia symptoms during the study
- •No TCM in last 3 months (including acupuncture, Chinese herbs or herbal tea pills, tuina (Chinese massage), shiatsu (Japanese massage), qigong and Oriental food therapy)
- •Ability to travel to the intervention and testing sites up to two times weekly
- •Being over 18 and under 75 years of age, and
- •Capability of giving informed consent.
排除标准
- •Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture;
- •Individuals with celiac disease
- •A score greater than 29 on the Beck Depression Inventory
- •Presence of concurrent autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, that causes pain and could potentially confound the analysis;
- •Routine daily use of narcotic analgesics or history of substance abuse;
- •Concurrent participation in other therapeutic trials;
- •Pregnant and nursing mothers (verification of pregnancy status will be determined via a urine test);
- •Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years);
- •Are undergoing disability determination, or are involved in litigation related to fibromyalgia
- •Any impairment, activity or situation that in the judgment of the PI would prevent satisfactory completion of the study protocol
- •Cognitive behavioral therapy in the last 6 months.
- •Non-fluency in English
结局指标
主要结局
Treatment Participation Rate
时间窗: 10 weeks
Rates of treatment attendance in both arms
次要结局
- Fibromyalgia Impact Questionnaire Revised(Weeks 0, 5, 10, and 14)
- Completion of Evaluation Rates(Weeks 0, 5, 10 and 14)
- Drop out rate(10 and 14 weeks)
- Nociceptive Reflex Testing(Weeks 0, 5, 10 and 14)
- Sleep Quality and Daily Activity(Weeks 0, 5, 10, and 14)
研究者
Scott Mist
Assistant Professor
Oregon Health and Science University
研究点 (2)
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