Mindfulness to Improve Functional Outcomes in Patients With Fibromyalgia or Central Sensitization: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Feasibility: Number of participants who complete the study
研究概览
简要总结
The primary aim of the study will be to determine the feasibility of utilizing a web-based mindfulness program in adult patients with chronic pain with a diagnosis of fibromyalgia or central sensitization.
详细描述
Chronic pain has a substantial economic cost and rate of impairment. Patients who suffer from fibromyalgia and other pain conditions leading to central sensitization have limited treatment options. The only medications currently approved by the Food and Drug Administration (FDA) for the treatment of fibromyalgia includes pregabalin, milnacipran and duloxetine. The International Association for the Study of Pain (IASP) also recommends the implementation of an exercise program and cognitive behavioral therapy. A previous meta-analysis found weak evidence to support Mindfulness-Based Stress Reductions (MBSR) in fibromyalgia patients, however more robust clinical studies are needed. In the midst of an opioid crisis, MBSR provides a safer alternative for the treatment of chronic pain. Unfortunately, an instructor lead MBSR program is both costly and largely unavailable in rural areas of the country. This web-based mindfulness program provides a treatment option for patients who would otherwise, not have access to alternative medicine therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 30-65
- •Patients with a diagnosis of fibromyalgia or central sensitization for greater than 6 months who are referred to the Interventional Pain Clinic
排除标准
- •Patients on greater than 120 morphine equivalents per day
- •Patients with untreated psychological illness
- •Patients already enrolled in ongoing trials involving pain management and treatment interventions
- •Patients currently undergoing treatment at the Osher Center for Integrative Health or patients with previous or current training in mindfulness.
结局指标
主要结局
Feasibility: Number of participants who complete the study
时间窗: 17 weeks
Number of participants who complete the study
次要结局
- Change in mean Five Facet Mindfulness Questionnaire (FFMQ) score(Baseline and 17 weeks)
- Global Change(17 weeks)
- Change in median Patient Reported Outcomes Measurement Information Systems-29 (PROMIS_29) score(Baseline and 17 weeks)
- Change in Pain Catastrophizing Scale (PCS)(Baseline and 17 weeks)
研究者
Jenna Walters
Assistant Professor of Anesthesiology and Pain Medicine
Vanderbilt University Medical Center
