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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG034078-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral-Mindfulness | Active Comparator | Mindfulness Meditation |
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| Behavioral-Health | Placebo Comparator | Health Education Class |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Meditation | Behavioral | 8-week mindfulness based program will be compared to and education control group |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the Roland-Morris Questionnaire | The Roland-Morris Questionnaire is a disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The RMQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain | Change from Baseline to 8-weeks to 6-months to 12-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Natalia Morone, MD, MS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26903081 | Derived | 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. | |
| 22115971 | Derived | 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. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Health Education | Behavioral | 8-week health education program |
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