跳至主要内容
临床试验/NCT03693274
NCT03693274终止不适用

Mindfulness to Improve Functional Outcomes in Patients With Fibromyalgia or Central Sensitization: A Pilot Feasibility Study

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年1月2日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jenna Walters

Assistant Professor of Anesthesiology and Pain Medicine

Vanderbilt University Medical Center

研究点 (2)

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