Functional Impact of PENS for 65+ Chronic Low Back Pain

描述（由申请人提供）：慢性腰痛（CLBP）困扰着超过600万社区居住的老年人，并导致身体和心理功能障碍以及卫生保健资源的利用率增加。虽然对这些个体的主要治疗包括非阿片类镇痛药和物理治疗（PT），但症状未缓解的体弱老年人的治疗选择有限。阿片类镇痛药和手术治疗可能不适用于那些有禁止性身体或认知合并症的患者。许多患有慢性肌肉骨骼疼痛的人寻求补充和替代治疗，尽管大多数还没有经过严格的科学研究。针灸是这些方式中最常用的。本研究的目的是探讨经皮神经电刺激（PENS），一种神经解剖引导形式的电针，作为一种安全的非药物镇痛替代方法，用于老年CLBP患者。为了优化身体表现和减少残疾，还将研究有或没有钢笔的一般调节和有氧运动（GCAE）计划的价值。将进行随机对照临床试验。200名65岁或以下的社区居住老年人将接受(1)单独的PENS，(2)单独的假PENS， (3) PENS + GCAE，或(4)假PENS + GCAE，每周两次，持续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。主要结果测量包括疼痛强度（短形式McGill疼痛问卷）和疼痛相关残疾（Roland残疾量表）。由于慢性疼痛是一种复杂的、多维度的体验，因此还将收集重要的次要结果测量，以评估(1)身体功能（自我报告和基于表现的），(2)社会心理功能（情绪、自我效能、自评健康、认知应对、恐惧、睡眠）和(3)医疗保健利用的关键方面。这项研究首次对老年人CLBP的替代药物干预进行了控制良好的全面检查。如果有效，这项试验可以改善数百万受苦的美国老年人的生活质量，并通过减少疼痛强度和使用有毒镇痛方案，通过减少医疗保健的利用，节省大量费用。

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.