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Effects of Meditation on Multiple Sclerosis and Peripheral Neuropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00981643
First received: September 21, 2009
Last updated: February 28, 2017
Last verified: September 2011

September 21, 2009
February 28, 2017
February 2009
November 2009   (Final data collection date for primary outcome measure)
Does meditation have a beneficial effect on pain, fatigue and physical functioning in patients with multiple sclerosis and peripheral neuropathy [ Time Frame: 2 months ]
To determine if meditation has a beneficial effect on pain, fatigue and physical functioning in patients with multiple sclerosis and peripheral neuropathy [ Time Frame: 2 months ]
Complete list of historical versions of study NCT00981643 on ClinicalTrials.gov Archive Site
Does meditation lead to improvements in the neurological evaluation with regards to weakness and sensory changes with meditation. [ Time Frame: 2 months ]
To determine, in the neuropathy arms, if there is an improvement seen on the neurological evaluation with regards to weakness and sensory changes with meditation [ Time Frame: 2 months ]
Not Provided
Not Provided
 
Effects of Meditation on Multiple Sclerosis and Peripheral Neuropathy
The Effects of Meditation on Pain, Fatigue and Physical Functioning in Patients With Multiple Sclerosis and Peripheral Neuropathy
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.
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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Supportive Care
  • Multiple Sclerosis
  • Peripheral Neuropathy
Behavioral: Meditation instruction and practice
Meditation techniques introduced and practiced, in a group setting, once weekly for 8 weeks
  • Experimental: Multiple Sclerosis, Meditation group
    Multiple Sclerosis, Meditation instruction and practice group
    Intervention: Behavioral: Meditation instruction and practice
  • No Intervention: Multiple Sclerosis, Control group
    Multiple Sclerosis, Control group
  • Experimental: Peripheral Neuropathy, Meditation group
    Peripheral Neuropathy, Meditation instruction and practice group
    Intervention: Behavioral: Meditation instruction and practice
  • No Intervention: Peripheral Neuropathy, Control group
    Peripheral Neuropathy, Control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2010
November 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of multiple sclerosis OR peripheral neuropathy

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00981643
CCF 08-950
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
No
Not Provided
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Jinny Tavee, MD The Cleveland Clinic
The Cleveland Clinic
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP