Mindfulness Meditation for Chronic Low Back Pain in Older Adults
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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 |
- 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) |
-
Behavioral: Mindfulness (MBSR)
Show Detailed Description Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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 Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013