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Mindfulness Meditation for Chronic Low Back Pain in Older Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00494845
First received: June 28, 2007
Last updated: February 24, 2011
Last verified: February 2011
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Mindfulness Meditation for Chronic Low Back Pain in Older Adults

Resource links provided by NLM:


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
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Mindfulness (MBSR)
    8-week mindfulness based stress reduction program will be compared to an education control group.
    Behavioral: Control: Health Education Class
    8-week education program
  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Natalia Morone, MD, MS University of Pittsburgh
  More Information

No publications provided

Responsible Party: Vincent Losasso Research Assistant, University of Pittsburfh
ClinicalTrials.gov Identifier: NCT00494845     History of Changes
Other Study ID Numbers: PRO07020074
Study First Received: June 28, 2007
Last Updated: February 24, 2011
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

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014