Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT01405716
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01405716
Study Brief:
Protocol Section:
NCT01405716