Mindfulness to Improve Functional Outcomes in Patients With Fibromyalgia or Central Sensitization
赞助:
Vanderbilt University Medical Center
合作者:
信息的提供 (责任方):
Jenna Walters,Vanderbilt University Medical Center
追踪信息 | |||
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首次提交日期 ICMJE | September 30, 2018 | ||
首次发布日期e ICMJE | October 2, 2018 | ||
最后更新发布日期 | October 2, 2018 | ||
预计研究开始日期 ICMJE | October 2018 | ||
预计主要完成日期 | October 2020 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Feasibility: Number of participants who complete the study[ Time Frame: 17 weeks ] Number of participants who complete the study |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Mindfulness to Improve Functional Outcomes in Patients With Fibromyalgia or Central Sensitization | ||
正式标题 ICMJE | Mindfulness to Improve Functional Outcomes in Patients With Fibromyalgia or Central Sensitization: A Pilot Feasibility Study | ||
简要概况 | 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. |
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详细说明 | 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. | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Supportive Care |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
30 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | October 2020 | ||
预计主要完成日期 | October 2020 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - 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 Exclusion Criteria: - 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. | ||
性别 |
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年龄 | 最小年龄:30 Years ,最大年龄:65 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | United States | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Jenna Walters,Vanderbilt University Medical Center | ||
研究赞助商 ICMJE | Vanderbilt University Medical Center | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | Vanderbilt University Medical Center | ||
验证日期 | September 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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