Mindfulness Meditation for Chronic Low Back Pain in Older Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
3.0 Research Design and Methods This pilot experimental study is designed as a randomized, education controlled clinical trial of mindfulness meditation for CLBP. A sample of 80 older adults 65 years of age and older will be recruited from a chronic pain clinic, general medicine research registry, posted flyers, and newspaper advertisements over an 18-month period. Eligibility will be determined by self-report from a checklist reviewed with potential participants over the phone. Pre-intervention study participants will be consented and study measures obtained. After consent and baseline measures, participants will be randomized using a simple randomization process with no stratification using a software generated randomization plan. After randomization, participants in the intervention group will receive the intervention of eight weekly 90-minute mindfulness meditation sessions. Controls will receive an 8-week health education program. Subject evaluation and each program will occur at the University of Pittsburgh Center for Research on Health Care (CRHC) which has subject examination areas as well as a classroom and a nearby parking structure. Subjects will be assessed weekly over the telephone during the intervention or health education program with a subset of measures administered at baseline. Immediately post-intervention or education program the complete set of measures will be administered again to participants and controls. Subjects will be assessed monthly by telephone for five months after completion of the MBSR or health education program with the same subset of baseline measures. Six months after the intervention is completed, participants will be asked to return to the CRHC and complete the entire set of measures a third time and any mindfulness meditation the intervention group continues to do at home will be quantified.
3.2 Procedures
3.2.2 Entry Phase: All 40 subjects who are included based upon the screening criteria will receive identical pre-treatment baseline assessments. Data will be collected and interviewer-administered by a trained research assistant at the University of Pittsburgh CRHC.
After successful telephone screening, written informed consent, and baseline examination, all eligible research subjects entering this study will be randomized into one of two treatment groups; 1) education group (control) or 2) mindfulness meditation (treatment). The randomization process will be performed using statistical software with a random-number generator to generate a randomization list before the study commences.
3.2.4 Intervention Phase: Participants will be seen in a group format once a week for 90 minutes for 8-weeks. All sessions will be led by a facilitator experienced in teaching the MBSR program and who has undergone teacher training in at least one intensive (≥ 50 hours) MBSR teacher training program conducted by the University of Massachusetts Medical School Center for Mindfulness prior to the intervention. All sessions will occur at the University of Pittsburgh Center for Research on Health Care (CRHC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention
8-week Mindfulness Program for chronic low back pain
干预措施: Mindfulness (Behavioral)
Comparison
8-week health education program
干预措施: Control: Health Education Class (Behavioral)
结局指标
主要结局
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.
时间窗: One year
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.
时间窗: One year
Determine the impact of time and frequency of mindfulness meditation on physical function and pain severity.
时间窗: One year
次要结局
未报告次要终点
研究者
Natalia Morone
Associate Professor
University of Pittsburgh