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临床试验/NCT00981643
NCT00981643已完成不适用

The Effects of Meditation on Pain, Fatigue and Physical Functioning in Patients With Multiple Sclerosis and Peripheral Neuropathy

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Does meditation have a beneficial effect on pain, fatigue and physical functioning in patients with multiple sclerosis and peripheral neuropathy

研究概览

简要总结

This study will evaluate the effects of mindfulness and concentration meditation on pain, fatigue, and physical functioning in patients with either multiple sclerosis or peripheral neuropathy.

详细描述

We propose a prospective, randomized controlled study evaluating the effects of mindfulness meditation and concentration meditation on pain, fatigue, and physical functioning in patients with either multiple sclerosis MS or a generalized polyneuropathy (PN). A secondary endpoint for the MS arm will include spasticity and for the PN arm will be the physical examination findings of sensory changes and weakness. Meditation classes of 90 minutes duration will be led by a Buddhist monk with over 20 years experience in meditation. Sessions will be held once weekly over a 3-month period. There will be an initial introduction session that will last approximately 180 minutes for the adminsitration of formal instructions and a training session on how to do the meditation. Outcome assessments will be answered electronically on a secure system or in written form that will be able to be completed at home or at the site of the meditation class. The data will be directly downloaded into a queriable database. Outcome assessments will be based on the Short Form (SF)-36 health survey and Visual Analog Scale (VAS) for pain at baseline and at 3 months. Additionally, the Neuropathy Impairment Score (NIS) will be used for the PN pts. The PDDS spasticity questionnaire and the fatigue portion of the MSQLI for fatigue will be used for the MS patients. We plan to recruit adult patients with either MS or PN through the current patient population in the Mellen Center and Neuromuscular Center and flyers placed throughout the Cleveland Clinic. Patients will be excluded if they have performed meditation within the last 6 months, are cognitively impaired, or have an underlying illness that would preclude comprehension of the instructions. Other exclusion criteria include a history of symptomatic cardiopulmonary disease, uncontrolled HTN, current alcohol or drug abuse, and kidney or renal failure. Patients must be ambulatory and able to toilet themselves.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosis of multiple sclerosis OR peripheral neuropathy

排除标准

  • Unable to walk without the assistance of others
  • Unable to toilet independently
  • Currently abusing drugs or alcohol
  • Have performed meditation within the last 6 months
  • Cognitive impairment or an underlying illness which would prevent the comprehension of instructions
  • History of symptomatic/unstable heart or lung disease
  • Uncontrolled high blood pressure
  • Kidney or renal failure

结局指标

主要结局

Does meditation have a beneficial effect on pain, fatigue and physical functioning in patients with multiple sclerosis and peripheral neuropathy

时间窗: 2 months

次要结局

  • Does meditation lead to improvements in the neurological evaluation with regards to weakness and sensory changes with meditation.(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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