Status:
COMPLETED
Aging Successfully With Pain
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Low Back Pain
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
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
Detailed Description
Among mind-body therapies, there is evidence for an association between pain reduction and mindfulness meditation. Mindfulness meditation provides a potentially safe, effective, nonpharmacologic, noni...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT01405716
Start Date
February 1 2011
End Date
September 1 2015
Last Update
October 3 2017
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213