Functional Impact of PENS for 65+ Chronic Low Back Pain

描述(申请人提供)：慢性下腰痛(CLBP)困扰着600多万居住在社区的老年人，并导致身体和心理社会功能障碍以及卫生保健资源利用率的增加。虽然这些人的主要治疗方法是非阿片类止痛药和物理治疗(PT)，但症状未缓解的虚弱老年人的治疗选择有限。阿片类镇痛剂和手术治疗可能不适用于那些患有禁止性身体或认知并存的人。许多慢性肌肉骨骼疼痛患者寻求补充和替代治疗，尽管大多数人没有经过严格的科学调查。针灸是这些方法中最常用的方法之一。本研究的目的是探讨经皮神经电刺激(PENS)--一种神经解剖学指导的电针形式--作为老年人CLBP的一种安全的非药物止痛剂的应用。为了优化体能和减少残疾，还将研究有无钢笔的普通调理和有氧运动(GCAE)计划的价值。将进行随机对照临床试验。200名患有CLBP的65岁或以上社区居住的老年人将收到(1)钢笔，(2)仅假钢笔，(3)钢笔+GCAE，或(4)假钢笔+GCAE，每周两次，为期6周。所有结果测量将在治疗前、6周方案完成时和6个月后收集。主要结果包括疼痛强度(简写麦吉尔疼痛问卷)和疼痛相关残疾(罗兰残疾评分)。由于慢性疼痛是一种复杂的、多维的体验，因此还将收集重要的次要结果指标，以评估(1)身体功能(自我报告和基于表现)、(2)心理社会功能(情绪、自我效能、自我评估健康、认知应对、恐惧、睡眠)和(3)卫生保健利用的关键方面。这项研究代表了对老年人CLBP的替代药物干预的第一次良好控制的全面检查。如果有效，这项试验可能会改善数百万遭受痛苦的美国老年人的生活质量，并通过减轻疼痛强度和使用有毒止痛药方案，通过减少医疗保健利用率来大幅节省成本。

DESCRIPTION (provided by applicant): Chronic low back pain (CLBP) plagues greater than 6 million community dwelling older adults, and causes physical and psychosocial dysfunction as well as increased utilization of health care resources. While the mainstay of treatment for these individuals consists of non-opioid analgesics and physical therapy (PT), frail older adults with unrelieved symptoms have limited therapeutic alternatives. Opioid analgesics and surgical treatment may be inapplicable to those with prohibitive physical or cognitive comorbidities. Many individuals with chronic musculoskeletal pain seek out complementary and alternative treatments, although most have not been subjected to rigorous scientific investigation. Acupuncture is among the most commonly employed of these modalities. The purpose of this investigation is to explore the utility of percutaneous electrical nerve stimulation (PENS), a neuroanatomically guided form of electroacupuncture, as a safe non-pharmacologic analgesic alternative for the older adult with CLBP. In order to optimize physical performance and diminish disability, the value of a general conditioning and aerobic exercise (GCAE) program with and without PENS will also be studied. A randomized controlled clinical trial will be performed. Two hundred community dwelling older adults equal to or > age 65 with CLBP will receive either (1) PENS alone, (2) sham PENS alone, (3) PENS + GCAE, or (4) sham PENS + GCAE, twice a week for 6 weeks. All outcome measures will be collected pre-treatment, at the completion of the 6 weeks protocol, and 6 months later. Primary outcome measures include pain intensity (short form McGill Pain Questionnaire) and pain-related disability (Roland Disability Scale). Because chronic pain is a complex, multidimensional experience, important secondary outcome measures will also be collected that assess key aspects of (1) physical function (self-reported and performance-based), (2) psychosocial function (mood, self-efficacy, self-rated health, cognitive coping, fear, sleep), and (3) health care utilization. This study represents the first well-controlled, comprehensive examination of an alternative medicine intervention for CLBP in older adults. If effective, this trial could lead to improved quality of life for millions of suffering older Americans, and by diminishing pain intensity and the use of toxic analgesic regimens, lead to substantial cost savings by decreasing health care utilization.