Improving Disability in Knee Osteoarthritis by Targeting Neuromuscular Deficits

通过针对神经肌肉缺陷改善膝骨关节炎的残疾

• 批准号: 9131614
• 负责人: Brian Pietrosimone
• 金额: $ 16.72万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9131614
• 关键词: Adherence; Affect; Biomechanics; Clinic; Clinical; Clinical Research; Clinical Trials; Communities; Data; Development; Disabled Persons; Disease; Economic Burden; Effectiveness; Evaluation; Exhibits; Future; Gait; Goals; Health; Impairment; Intervention; Investments; Knee; Knee Osteoarthritis; Laboratories; Lead; Medical Research; Mission; Motor; Muscle Contraction; Muscle Weakness; Nerve; Neural Pathways; Operative Surgical Procedures; Outcome; Outpatients; Pain; Patient Self-Report; Patients; Physical Function; Physical activity; Physical therapy; Public Health; Publishing; Quality of life; Randomized Clinical Trials; Randomized Controlled Trials; Rehabilitation therapy; Reporting; Research; Research Proposals; Self Efficacy; Testing; Therapeutic; Therapeutic exercise; Transcutaneous Electric Nerve Stimulation; Translating; United States; United States National Institutes of Health; Work; base; burden of illness; cohort; compliance behavior; cost effective; disability; evidence base; group intervention; improved; improved outcome; innovation; muscle strength; neuromuscular; novel; primary outcome; programs; quadriceps muscle; randomized trial; rehabilitation paradigm; rehabilitation strategy; secondary outcome

 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.

 描述（由适用提供）：该R21试验的重点和可行性临床研究建议是使用经皮的电神经刺激（TENS），用于治疗膝盖骨关节炎（OA）患者中神经肌肉激活的新指示，使神经性神经肌肉肌肉激活不足。总体目标是通过制定增强的康复策略来改善与传统治疗锻炼相关的结果，该策略以数十个（TENS+TE）增强TE，以治疗潜在的神经肌肉激活缺陷。大约75％的膝关节OA患者患有神经肌肉激活缺陷，导致残疾并阻碍TE干预措施可以实现的力量增长。基于申请人的先前发表的工作，该工作在高度控制的实验室中进行了数十个激发的神经肌肉，从而立即增加了神经肌肉激活。同样，与传统TE相比，TENS+TE在膝盖OA患者的神经肌肉激活和强度增长方面持续改善。有必要将增强的康复策略转化为基于社区的物理疗法（PT）诊所，以提高非手术康复对膝关节OA患者的益处。 R21的目的是报告可行性并确定使用TENS靶向神经肌肉激活缺陷的初步效果，并增强PT诊所中提供给膝关节OA患者的传统TE。我们将评估TENS+TE对肌肉强度，神经肌肉激活，步态生物力学，身体机能，身体活动，自我效能的影响 体育锻炼，自我报告的生活质量，残疾和痛苦。中心假设是增强的TENS+TE干预措施将导致更好的临床结果，增加体育锻炼并改善一般健康状况。进行小型临床试验的理由，该试验证明了可行性并确定了增强的康复策略的初步影响，最终是为了确定未来更大的临床试验的发展，以确立增强膝关节康复策略的有效性。该假设将通过两个具体目的进行检验：1）收集和报告可行性数据，以进行未来的随机临床试验，以评估使用TENS+TE的有效性与Sham Tens+TE相比，仅在膝盖OA中仅在膝盖OA中进行TE，以及2）确定与4周Tens+TE Interigention的初步效果相比，与Sham TENS+TEENICTION相比，te和te te te和te的效果仅在本机上进行了效果，并在te+te中进行了效果。身体功能，体育锻炼，自我效能 膝关节OA患者的体育锻炼，自我报告的生活质量，残疾和疼痛。基线后的后味为4周和8周。这种方法具有创新性，因为它引入了一种新颖的指示，并简单地开发出一种新的，增强的康复范式，该范式靶向神经肌肉激活不足，这是传统TE目前忽略的损害。拟议的随机对照试验的结果对于制定未来的临床试验将很重要，以建立膝关节康复范式范围的证据基础。