Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
282 participants
INTERVENTIONAL
2011-02-28
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Behavioral-Mindfulness
Mindfulness Meditation
Mindfulness Meditation
8-week mindfulness based program will be compared to and education control group
Behavioral-Health
Health Education Class
Health Education
8-week health education program
Interventions
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Mindfulness Meditation
8-week mindfulness based program will be compared to and education control group
Health Education
8-week health education program
Eligibility Criteria
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Inclusion Criteria
* Have intact cognition (Mini-Mental Status Exam (MMSE) \>24)
* 65 years of age or older.
* Have functional limitations due to their low back, defined as a score of at least 12 on the Roland and Morris Disability Questionnaire.
* CLBP, defined as moderate pain occurring daily or almost every day for at least the previous three months.
* Speak English.
* 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.
* Have 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 and data validity. For example, the Mini-Mental Status Exam has never been validated in those with severe visual or hearing disturbance.
* Have pain in other parts of the body that is more severe than their low back pain, \[defined as pain other than in the lower back that occurs daily or almost every day and is of at least moderate intensity\] or acute back pain: since we will be specifically evaluating chronic low back pain, we do not want to confound the outcome data with \[significant pain\] from other areas or with acute pain. Thus only participants with chronic low back pain severity that is greater than pain severity elsewhere in the body will be included.
* Have acute or terminal illness: To insure weekly participation and a twelve month follow-up, participants with an acute or terminal illness will be excluded from the study.
* Have moderate to severe depression, defined as a Geriatric Depression Scale score of 21 and above: since active depression may affect the psychological outcomes of the study and may affect compliance with participation in the intervention and control programs.
* Do not have access to a telephone: since monthly assessments will be done over the telephone.
65 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Natalia Morone
Associate Professor
Principal Investigators
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Dr Natalia Morone, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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References
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Morone NE, Greco CM, Moore CG, Rollman BL, Lane B, Morrow LA, Glynn NW, Weiner DK. A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):329-37. doi: 10.1001/jamainternmed.2015.8033.
Morone NE, Greco CM, Rollman BL, Moore CG, Lane B, Morrow L, Glynn NW, Delaney J, Albert SM, Weiner DK. The design and methods of the aging successfully with pain study. Contemp Clin Trials. 2012 Mar;33(2):417-25. doi: 10.1016/j.cct.2011.11.012. Epub 2011 Nov 15.
Other Identifiers
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PRO09100150
Identifier Type: -
Identifier Source: org_study_id