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

描述(由申请人提供)： 慢性下腰痛(CLBP)是美国退伍军人中最常见和最致残的疾病之一，其患病率上升的速度甚至比糖尿病和高血压等其他慢性疾病更快。研究表明，体力活动(PA)可以改善慢性下腰痛患者的预后，但这项研究的一个主要空白是缺乏针对老年人的研究；患者样本主要是中年人，并包括少数年龄为65岁的患者。因此，我们缺乏证据来证明PA干预在慢性下腰痛患者这一弱势群体中的可行性和有效性。这一点尤其重要，因为越来越多的证据表明，患有慢性下腰痛的老年人有明显的下肢功能限制，导致难以执行必要的日常任务。在患有慢性下腰痛的老年人中，另一个有限的调查领域是，将疼痛管理认知行为疗法(CBT-P)技能与PA干预相结合是否有额外的好处。CBT-P有助于重建PA的痛觉，改善PA的起搏。一些慢性下腰痛患者对单独的PA干预反应不佳，这可能是疼痛敏感度增强可能是导致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，对疼痛敏感度更高的cLBP老年人可能对PA和CBT-P(与单独使用PA相比)的联合方案反应更好；然而，这一点尚未被研究。这一信息对一项更大规模的试验具有实际意义，以确定是否有较高中枢性疼痛敏感性的患者子集可能需要额外的干预来补充PA计划。我们将对为期12周的以家庭为基础的PA和PA+CBT-P项目进行试点研究，这两个项目都有每周的电话支持，并与等待名单对照组进行比较。参与者将是60名患有慢性下腰痛的老年退伍军人(年龄为65岁)。参与者将通过Durham VAMC的老年和初级保健诊所的转介进行登记。PA项目将是综合性的，包括伸展、强化和有氧活动，活动的具体类型和强度将面向老年人。CBT-P课程将包括五种不同的技能，编织到基于电话的课程中，具体应用于PA和cLBP。这两种干预措施将由一名物理治疗师和一名运动顾问联合提供，他们拥有互补的专业知识领域(例如，分别进行临床运动处方培训和激励性面谈技能培训，以鼓励PA遵守)。电话通话将涉及特定患者的目标设定，并解决PA和CBT-P技能的障碍。参与者将收到一本小册子，里面有伸展和加强练习的说明和照片，以及一段适合患有慢性下腰痛的老年人的运动视频。联合干预的参与者还将收到有关CBT-P技能的书面和音频指导。可行性指标将包括完成的干预电话的比例，遵守以家庭为基础的PA建议和CBT-P技能使用，以及参与者对计划的反馈。结果将在基线和12周的随访中进行评估。疗效的主要衡量标准将是对一般身体功能的评估，既有客观的(定时起跳、爬楼梯)，也有自我报告的(PROMIS健康评估问卷)。次要结果将包括测量特定于cLBP的疼痛和残疾。中枢疼痛敏感性将通过疼痛压力阈值(PPT)测试和中央敏感量表(CSI)进行评估。统计分析将包括比较各研究组的基线和随访结果，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.