Phase 3 Double Blind Randomized Study Comparing Drug Treatment (Tramadol Versus Placebo) and Behavioral Health Treatments (Cognitive Behavioral Therapy Versus Health Education) for Patients With Fibromyalgia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function
研究概览
简要总结
This is a randomized control study that involves a combination of a drug treatment, behavioral health, and placebo controls.
Some participants will receive a medication approved by the Food and Drug Administration for treatment of moderate to moderately severe pain called Tramadol HC1 IR. Others will receive an inactive pill, called a placebo. There will also be 2 different types of behavioral health treatments, Cognitive-Behavior Therapy (CBT) and Health Education (HE) both of which have been recommended for the treatment of patients with FM by the American Pain Society.
There are 4 possible study treatment combinations:
- Tramadol + CBT,
- Tramadol + HE,
- Placebo + CBT,
- Placebo + HE.
Although Tramadol, CBT, and HE have been shown to have some benefits for FM patients, there have been no studies that have evaluated the combination of medication and a behavioral health treatment. The primary purpose of this study is to compare the benefits of the 4 combinations listed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females 21-70
- •Diagnosis of Fibromyalgia
- •Current primary care physician
- •Fluent in English
排除标准
- •Rheumatologic disorders
- •Drug and alcohol abuse in the past year
- •Psychiatric hospitalization in the past 6 months
- •Current use of Tramadol
- •Certain antidepressant and other pain medications
研究组 & 干预措施
Tramadol
干预措施: Tramadol (Drug)
Placebo
干预措施: Placebo (Drug)
Cognitive Behavior Therapy for FM
干预措施: Cognitive Behavior Therapy for FM (Behavioral)
Health Education
干预措施: Health Education (Behavioral)
结局指标
主要结局
Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function
时间窗: Baseline (one week prior to drug titration) to post-treatment (approximately 11 weeks after baseline).
The primary outcome is a reduction of at least 30% on the pain score (mean for 5-day daily pain diary) or improvement of 20% physical function (FIQR) from baseline (pre-treatment) to post-treatment. Individuals who achieve such decrease in pain or increase in function are labeled "responders."
次要结局
未报告次要终点
研究者
Dennis Turk
Professor, Anesthesiology
University of Washington