Mindfulness Meditation for Chronic Low Back Pain in Older Adults - Full Text View

Purpose

Among mind-body therapies, there is evidence for an association between pain reduction and mindfulness meditation. Mindfulness meditation provides a potentially safe, effective, nonpharmacologic, noninvasive, simple method for pain relief and increased function that could be used for the frailest older adult. Additionally, mindfulness meditation addresses the multiple dimensions that are affected by chronic pain. The primary objective of this study is to determine the impact of an 8-week mindfulness-based stress reduction program on physical function and pain severity in community dwelling older adults with chronic low back pain. Using a randomized controlled experimental design, 80 community dwelling older adults ≥ age 65 with chronic low back pain will receive either (1) the MBSR program, or (2) an 8-week education program. Prior to initiating the program, immediately after the last program session, and 6 months later, the following parameters will be assessed: (1) pain severity, (2) disability/physical function, (3) objectively measured physical performance, (4) psychosocial function (including mood, self-efficacy, self-rated health, coping, stress, quality of life (QOL), mindfulness and pain-related fear), (5) sleep, (6) pain-related appetite reduction and, (7) time and frequency of meditation. All measures are self-report except for the physical performance measure.

Condition	Intervention
Low Back Pain	Behavioral: Mindfulness (MBSR) Behavioral: Control: Health Education Class

MedlinePlus related topics:

Back Pain Stress

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Official Title:	Mindfulness Meditation for Chronic Low Back Pain in Older Adults

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Determine the impact of an 8-week mindfulness-based stress reduction program on physical function and pain severity in community dwelling older adults with chronic low back pain. [ Time Frame: One year ] [ Designated as safety issue: No ]
Determine the impact of an 8-week mindfulness-based stress reduction program on psychosocial function, sleep, and appetite in older adults with chronic low back pain. [ Time Frame: One year ] [ Designated as safety issue: No ]
Determine the impact of time and frequency of mindfulness meditation on physical function and pain severity. [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	July 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

8-week mindfulness based stress reduction program will be compared to an education control group.

8-week education program

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Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

65 years of age or older
Have intact cognition (Mini-Mental Status Exam (MMSE) >23)
CLBP, defined as moderate pain occurring daily or almost every day for at least the previous three months
Speak English.

Exclusion Criteria:

Do not meet the above inclusion criteria
Have previously participated in a mindfulness meditation program
Have serious underlying illness (like malignancy, infection, unexplained fever, weight loss or recent trauma) causing their pain,
Are non-ambulatory, or have severely impaired mobility (i.e., require the use of a walker): since measurement of physical performance in the proposed study includes timed chair rise, gait velocity, and standing balance, conditions other than back pain that could negatively impact these measures may confound our study results
Severe visual or hearing impairment: since this study will involve questionnaires and telephone evaluations, severe visual and/or hearing impairments may interfere with data collection
Significant pain in parts of the body other than the lower back or acute back pain: since we will be specifically evaluating chronic low back pain, we do not want to confound the outcome data with pain from other areas or with acute pain. Thus only subjects with chronic back pain severity that is greater than pain severity elsewhere in the body will be included
Acute or terminal illness: To insure weekly participation and a six month follow-up, subjects with an acute or terminal illness will be excluded from the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494845

Locations


United States, Pennsylvania
	University of Pittsburgh
	Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

National Center for Research Resources (NCRR)

Investigators


Principal Investigator:	Natalia Morone, MD, MSc	University of Pittsburgh

More Information

Responsible Party:	University of Pittsburfh ( Vincent Losasso Research Assistant )
Study ID Numbers:	PRO07020074
First Received:	June 28, 2007
Last Updated:	January 3, 2008
ClinicalTrials.gov Identifier:	NCT00494845
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Mindfulness

Elderly

Chronic Illness

Back Pain

Chronic Low Back Pain

Older adults over the age of sixty-five

MMSE score of over 23

Speaks English

Study placed in the following topic categories:

Signs and Symptoms

Neurologic Manifestations

Low Back Pain

Chronic Disease

Pain

Back Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on November 06, 2008

Sponsors and Collaborators:	University of Pittsburgh National Center for Research Resources (NCRR)
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00494845