Functional Impact of PENS for 65+ Chronic Low Back Pain

PENS 对 65 例慢性腰痛的功能影响

• 批准号: 6897770
• 负责人: DEBRA KAYE WEINER
• 金额: $ 35.67万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-01 至 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6897770
• 关键词: acupuncture /acupressure; alternative medicine; analgesia; backache; chronic pain; clinical research; clinical trials; cognition; electronic stimulator; exercise; functional ability; health care service utilization; human old age (65+); human subject; patient oriented research; psychosocial separation

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.

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，导致身体和心理社会功能障碍以及医疗保健资源的利用率增加。虽然这些人的主要治疗方法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患有严重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，尽管大多数都没有经过严格的科学研究。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)（一种神经解剖学引导的电针形式）作为患有 CLBP 的老年人的安全非药物镇痛替代方案的效用。为了优化身体表现并减少残疾，还将研究有或没有 PENS 的一般体能和有氧运动 (GCAE) 计划的价值。将进行随机对照临床试验。 200 名年龄等于或大于 65 岁的 CLBP 社区居住老年人将接受 (1) 仅 PENS，(2) 仅假 PENS，(3) PENS + GCAE，或 (4) 假 PENS + GCAE，每周两次6周。所有结果指标将在治疗前、6 周方案完成时和 6 个月后收集。主要结果指标包括疼痛强度（简式麦吉尔疼痛问卷）和与疼痛相关的残疾（罗兰残疾量表）。由于慢性疼痛是一种复杂、多维的经历，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）、(2) 心理社会功能（情绪、自我效能、自评健康状况、认知应对、恐惧、睡眠），以及 (3) 医疗保健利用。这项研究代表了对老年人 CLBP 的替代医学干预措施的首次控制良好的全面检查。如果有效，这项试验可能会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有毒镇痛疗法的使用，通过减少医疗保健利用率来节省大量成本。