Improving Disability in Knee Osteoarthritis by Targeting Neuromuscular Deficits

 描述(由申请人提供)：这项R21试点和可行性临床研究提案的重点是使用经皮神经电刺激(TENS)作为治疗膝关节骨关节炎(OA)患者神经肌肉激活的新适应症，这些患者表现出神经肌肉激活缺陷。总体目标是通过开发一种增强的康复策略来改善与传统治疗练习(TE)相关的结果，该策略以TENS(TENS+TE)为补充，目的是治疗潜在的神经肌肉激活缺陷。大约75%的膝骨性关节炎患者存在神经肌肉激活缺陷，这会导致残疾并阻碍可通过TE干预实现的力量增长。根据申请人之前发表的工作，在高度受控的实验室中进行，TENS刺激神经通路，立即增加神经肌肉激活；此外，与传统TE相比，TENS+TE在膝骨性关节炎患者的神经肌肉激活和更大的力量增加方面产生持续改善。有必要将增强的康复策略转化为以社区为基础的物理治疗(PT)诊所，那里通常发生TE，以提高膝骨性关节炎患者非手术康复的好处。本R21的目的是报告使用TENS靶向神经肌肉激活缺陷的可行性和初步效果，并增强PT临床中提供给膝骨性关节炎患者的传统TE。我们将评估TENS+TE对肌肉力量、神经肌肉激活、步态生物力学、身体功能、身体活动、自我效能的影响。 体力活动、自我报告的生活质量、残疾和疼痛。中心假设是，加强TENS+TE干预将导致更好的临床结果，增加体力活动，并改善总体健康。开展一项小型临床试验的基本原理是论证强化康复策略的可行性并确定其初步效果，最终是为了为未来更大规模的临床试验的发展提供信息，以确定强化康复策略对膝骨性关节炎的疗效。这一假设将通过两个特定的目标进行检验：1)收集和报告可行性数据，以便进行未来的随机临床试验，以评估TENS+TE与假TENS+TE以及仅在膝骨性关节炎患者中使用TENS+TE的疗效；2)确定为期4周的TENS+TE干预与Sham TENS+TE相比的初步效果，以及TE仅对肌肉力量、神经肌肉激活、步态生物力学、身体功能、体力活动、自我效能的影响 膝骨性关节炎患者的体力活动、自我报告的生活质量、残疾和疼痛。邮寄将在基线后4周和8周进行。这种方法是创新的，因为它为TENS引入了一种新的适应症，同时开发了一种新的、增强的康复范例，针对神经肌肉激活缺陷，这是一种目前被传统TE忽视的损伤。建议的随机对照试验的结果将对发展未来的临床试验，为膝骨性关节炎康复的范式转换建立证据基础具有重要意义。

 DESCRIPTION (provided by applicant): The focus of this R21 Pilot and Feasibility Clinical Research proposal is to use transcutaneous electrical nerve stimulation (TENS) for the novel indication of treating neuromuscular activation in knee osteoarthritis (OA) patients that exhibit neuromuscular activation deficits. The overall goal is to improve outcomes associated traditional therapeutic exercise (TE) by developing an enhanced rehabilitation strategy, which augments TE with TENS (TENS+TE), for the purpose of treating underlying neuromuscular activation deficits. Approximately 75% of knee OA patients have neuromuscular activation deficits that lead to disability and impede strength gains that can be achieved with TE interventions. Based on the applicant's prior published work, conducted in a highly controlled laboratory, TENS excites neural pathways that immediately increase neuromuscular activation; also, TENS+TE produces sustained improvements in neuromuscular activation and greater strength gains in knee OA patients compared to traditional TE. There is a need to translate the enhanced rehabilitation strategy into community-based physical therapy (PT) clinics, where TE typically occurs, to improve the benefits of non-surgical rehabilitation for knee OA patients. The objective of this R21 is to report the feasibility and determine the preliminary effects of using TENS to target neuromuscular activation deficits and enhance the traditional TE provided to knee OA patients in PT clinics. We will evaluate the effect of TENS+TE on muscle strength, neuromuscular activation, gait biomechanics, physical function, physical activity, self-efficacy of physical activity, self-reported quality of life, disability and pain. The central hypothesis is tht an enhanced TENS+TE intervention will lead to better clinical outcomes, increased physical activity, and improved general health. The rationale for conducting a small clinical trial, which demonstrates the feasibility and establishes the preliminary effects of an enhanced rehabilitation strategy, is ultimately to inform the development of a future larger clinical trial to establish th efficacy of an enhanced rehabilitation strategy for knee OA. This hypothesis will be tested through two specific aims: 1) to collect and report feasibility data for conducting a future randomized clinical trial to evaluate the efficacy of using TENS+TE compared to sham TENS+TE and to TE only in patients with knee OA, and 2) to determine preliminary effects of a 4-week TENS+TE intervention compared to sham TENS+TE, and TE only on muscle strength, neuromuscular activation, gait biomechanics, physical function, physical activity, self-efficacy of physical activity, self-reported quality of life, disability, and pain in knee OA patients. Posttess will be at 4 and 8-weeks following baseline. This approach is innovative because it introduces a novel indication for TENS and simultaneously develops a new, enhanced rehabilitation paradigm that targets neuromuscular activation deficits, an impairment currently ignored by traditional TE. The results from the proposed randomized controlled trial will be significant for developing a future clinical trial to establish the evidence base for a paradigm shift in knee OA rehabilitation.