View Clinical Trial (Medical Research Study)
Effectiveness of a Mind-Body Program for Older Adults With Chronic Low Back Pain
| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| Zip Code: |
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15213 |
| Conditions: |
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Low Back Pain |
| Purpose: |
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The primary objective of this study is to determine the effectiveness of a mind-body program
in increasing function and reducing pain among older adults with chronic low back pain
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| Study Summary: |
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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. This experimental study is designed as a
randomized, education controlled clinical trial of a mind-body program for older adults with
chronic low back pain. A sample of 300 independent, community-dwelling adults 65 years of
age and older will be recruited. After determining eligibility, study participants will give
written informed consent and will be randomized to either the mindfulness-based stress
reduction (MBSR) program or the health education control program. Participants in the
mind-body group will receive the intervention of eight weekly 90-minute mindfulness
meditation sessions that are modeled on the MBSR program. Controls will receive an 8-week
health education program based on the 10 Keys(TM) to Healthy Aging. After completion of the
8-week program, participants in both programs will be asked to return for 12 monthly booster
sessions. Prior to initiating the program, immediately after the last program session, and 6
& 12 months later, the following parameters will be assessed: (1) physical function, (2)
pain severity, (3) neuropsychological performance, (4) measures of mindfulness, (5)
demographic factors, and (6) biomedical factors.
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| Criteria: |
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Inclusion Criteria:
- 65 years or older
- 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.
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.
- 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.
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| NCT ID: |
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NCT01405716 |
| Primary Contact: |
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Principal Investigator
Dr Natalia Morone, MD, MS
University of Pittsburgh
Bridget Lane, MS
Phone: 412-586-9817
Email: laneb@upmc.edu
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| Backup Contact: |
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Email: delaneyjf2@upmc.edu
Jill Delaney, BSW
Phone: 412-692-2013
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| Location Contact: |
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Pittsburgh, Pennsylvania 15213
United States
Bridget Lane, MS
Phone: 412-586-9817
Email: laneb@upmc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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