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Effects of Meditation on Multiple Sclerosis and Peripheral Neuropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00981643
First Posted: September 22, 2009
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The Cleveland Clinic
  Purpose
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.

Condition Intervention
Multiple Sclerosis Peripheral Neuropathy Behavioral: Meditation instruction and practice

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of Meditation on Pain, Fatigue and Physical Functioning in Patients With Multiple Sclerosis and Peripheral Neuropathy

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Does meditation have a beneficial effect on pain, fatigue and physical functioning in patients with multiple sclerosis and peripheral neuropathy [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • Does meditation lead to improvements in the neurological evaluation with regards to weakness and sensory changes with meditation. [ Time Frame: 2 months ]

Enrollment: 40
Study Start Date: February 2009
Study Completion Date: December 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multiple Sclerosis, Meditation group
Multiple Sclerosis, Meditation instruction and practice group
Behavioral: Meditation instruction and practice
Meditation techniques introduced and practiced, in a group setting, once weekly for 8 weeks
No Intervention: Multiple Sclerosis, Control group
Multiple Sclerosis, Control group
Experimental: Peripheral Neuropathy, Meditation group
Peripheral Neuropathy, Meditation instruction and practice group
Behavioral: Meditation instruction and practice
Meditation techniques introduced and practiced, in a group setting, once weekly for 8 weeks
No Intervention: Peripheral Neuropathy, Control group
Peripheral Neuropathy, Control group

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981643


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Jinny Tavee, MD The Cleveland Clinic
  More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00981643     History of Changes
Other Study ID Numbers: CCF 08-950
First Submitted: September 21, 2009
First Posted: September 22, 2009
Last Update Posted: March 3, 2017
Last Verified: September 2011
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Cleveland Clinic:
Meditation
Multiple Sclerosis
Peripheral Neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neuromuscular Diseases