Effects of Meditation on Multiple Sclerosis and Peripheral Neuropathy

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981643
• Other study ID #: CCF 08-950
• Status: Completed
• Phase: N/A
• First received: September 21, 2009
• Last updated: February 28, 2017
• Start date: February 2009
• Est. completion date: December 2010

Study information

• Verified date: September 2011
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Sclerosis

Intervention

Behavioral:
• Meditation instruction and practice
Meditation techniques introduced and practiced, in a group setting, once weekly for 8 weeks

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does meditation have a beneficial effect on pain, fatigue and physical functioning in patients with multiple sclerosis and peripheral neuropathy		2 months
Secondary	Does meditation lead to improvements in the neurological evaluation with regards to weakness and sensory changes with meditation.		2 months