Physical Activity for older Adults with Chronic Low Back Pain: PACe-LBP

描述（由申请人提供）： 慢性腰痛（cLBP）是美国退伍军人中最常见和致残的疾病之一，其患病率比糖尿病和高血压等其他慢性疾病上升得更快。研究表明，体力活动（PA）可以改善cLBP患者的结局，但这项研究的一个主要差距是缺乏针对老年人的研究;患者样本主要是中年人，很少包括65岁以上的患者。因此，我们缺乏证据基础的可行性和有效性的PA干预措施在这一弱势群体的cLBP患者。鉴于越来越多的证据表明患有cLBP的老年人具有显著的下肢功能限制，导致难以执行必要的日常任务，这一点尤为重要。在患有cLBP的老年人中进行的另一个有限调查领域是，将认知行为疗法用于疼痛管理（CBT-P）技能与PA干预结合是否有额外的益处。CBT-P有助于重建PA的疼痛感觉和改善起搏。一些cLBP患者对单独的PA干预反应不佳，并且可能是疼痛敏感性增强可能是某些患者缺乏反应的原因。由于CBT-P已被证明可以改变疼痛处理，因此具有更大疼痛敏感性的cLBP老年人可能对PA和CBT-P（与单独PA相比）相结合的计划反应更好;然而，这尚未被研究。这一信息对更大规模的试验具有实际意义，以确定具有更高中枢疼痛敏感性的患者子集是否需要额外的干预来补充PA计划。 我们将进行一项为期12周的家庭PA和PA + CBT-P计划的试点研究，两者都有每周的电话支持，与等待名单对照组相比。参与者将是60名患有cLBP的老年退伍军人（年龄e65）。将通过达勒姆VAMC的老年和初级保健诊所的转诊招募受试者。PA计划将是全面的，包括伸展，加强和有氧活动，活动的具体类型和强度将面向老年人。CBT-P计划将包括五种不同的技能，编织到基于电话的会话中，具体应用于PA和cLBP。这两种干预措施将由物理治疗师和运动顾问联合提供，他们具有互补的专业领域（例如，临床运动处方和动机访谈技巧的培训，以鼓励PA的坚持，分别）。电话将涉及患者特定的目标设定，并解决PA和CBT-P技能的障碍。参与者将收到一本小册子，其中包含拉伸和加强运动的说明和照片，以及适合患有cLBP的老年人的运动视频。参与综合干预的人员还将收到有关CBT-P技能的书面和音频说明。可行性措施将包括完成干预电话的比例，坚持以家庭为基础的PA建议和CBT-P技能的使用，以及参与者对计划的反馈。将在基线和12周随访时评估结局。疗效的主要指标将是一般身体功能评估，包括客观（定时起身和行走、爬楼梯）和自我报告（PROMIS健康评估问卷）。次要结局将包括测量cLBP特异性疼痛和残疾。将通过疼痛压力阈值（PPT）测试和中枢致敏量表（CSI）评估中枢疼痛敏感性。统计分析将包括比较各研究组的基线和随访结局，以及根据基线PPT和CSI评分检查不同干预反应的潜在趋势。

DESCRIPTION (provided by applicant): Chronic low back pain (cLBP) is one of the most common and disabling conditions among US military veterans, and the prevalence is rising even more rapidly than other chronic conditions such as diabetes and hypertension. Studies have shown that physical activity (PA) can improve outcomes in patients with cLBP, but a major gap in this research is the lack of studies focusing on older adults; patient samples have been primarily middle-aged and have included few patients' age e65 years. Therefore, we lack an evidence base for the feasibility and effectiveness of PA interventions in this vulnerable group of patients with cLBP. This is particularly important given the accumulating evidence showing that older adults with cLBP have significant lower extremity functional limitations, resulting in difficulty performing necessay daily tasks. Another area of limited investigation among older adults with cLBP is whether there is added benefit of incorporating cognitive behavioral therapy for pain management (CBT-P) skills with PA interventions. CBT-P can help to restructure pain perception and improve pacing of PA. Some patients with cLBP do not respond favorably to isolated PA interventions, and it is possible that heightened pain sensitization may underlie this lack of response in some patients. Since CBT-P has been shown to alter pain processing, older adults with cLBP who have greater pain sensitization may respond better to a program that combines PA and CBT-P (vs. PA alone); however, this has not been studied. This information has practical implications for a larger trial to determining whether a subset of patients with greater central pain sensitivity may need additional intervention to supplement a PA program. We will conduct a pilot study of a 12-week home-based PA and PA + CBT-P programs, both with weekly telephone support, compared with a waiting list control group. Participants will be 60 older veterans (age e65) with cLBP. Enrollment of participants will occur via referrals from geriatric and primary care clinics a the Durham VAMC. The PA program will be comprehensive, including stretching, strengthening, and aerobic activities, and the specific types and intensities of the activities will be geared toward older adults. The CBT-P program will include five different skills, woven into the telephone-based sessions, with specific application to PA and cLBP. Both interventions will be jointly delivered by a physical therapist and exercise counselor, who has complementary areas of expertise (e.g., training in clinical exercise prescription and motivational interviewing skillsto encourage PA adherence, respectively). Telephone calls will involve patient-specific goal- setting and address barriers to PA and CBT-P skills. Participants will receive a booklet with instructions and photographs for stretching and strengthening exercises, as well as an exercise video appropriate for older adults with cLBP. Participants in the combined intervention will also receive written and audio instructions regarding CBT-P skills. Feasibility measures will include the proportion of completed intervention calls, adherence to home-based PA recommendations and CBT-P skills use, and participant feedback on the programs. Outcomes will be assessed at baseline and 12-week follow-up. Primary measures of efficacy will be assessments of general physical function, both objective (timed up-and-go, stair-climbing) and self-reported (PROMIS Health Assessment Questionnaire). Secondary outcomes will include measures cLBP-specific pain and disability. Central pain sensitivity will be assessed via Pain Pressure Threshold (PPT) testing and the Central Sensitization Inventory (CSI). Statistical analyses will include comparison of baseline and follow-up outcomes across study groups, as well as examination of potential trends for differential intervention response according to baseline PPT and CSI scores.