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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Peripheral Neuropathy
• Intervention / Treatment: Behavioral: Meditation instruction and practice

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Does meditation have a beneficial effect on pain, fatigue and physical functioning in patients with multiple sclerosis and peripheral neuropathy	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Does meditation lead to improvements in the neurological evaluation with regards to weakness and sensory changes with meditation.	2 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Jinny Tavee, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: September 21, 2009
• First Submitted That Met QC Criteria: September 21, 2009
• First Posted (Estimate): September 22, 2009

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Meditation; Peripheral Neuropathy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neuromuscular Diseases; Multiple Sclerosis; Sclerosis; Peripheral Nervous System Diseases
• Other Study ID Numbers: CCF 08-950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No