Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty

Обзор

Patients experience dramatic quadriceps strength loss after total knee replacement, which contributes to persistent weakness and reduced long-term function after surgery. Neuromuscular electrical stimulation (NMES) reduces quadriceps weakness and improves patient function after knee replacement, but it is drastically underused in rehabilitation practice. This randomized trial will examine the effectiveness and feasibility of a comprehensive strategy for implementing neuromuscular electrical stimulation after knee replacement in two large healthcare organizations.

Подробное описание

Total Knee Arthroplasty (TKA) reduces pain and disability caused by knee osteoarthritis, but the surgery results in substantial trauma to the knee. This acute trauma exacerbates underlying weakness-especially in the quadriceps. This leads to muscle atrophy and likely contributes to the long-term weakness and disability patients with TKA experience relative to their healthy peers. Attenuating quadriceps strength loss should be a primary target for improving rehabilitation outcomes after TKA.

Neuromuscular electrical stimulation (NMES) is recommended in TKA clinical practice guidelines to attenuate quadriceps strength loss. In controlled settings, NMES has established efficacy and attenuates quadriceps strength loss by 40% in the first month after surgery by overriding muscle activation deficits and reducing muscle atrophy. However, the effectiveness of NMES after TKA has not been adequately studied in real-world clinical settings, and preliminary data suggests that less than 4% of rehabilitation clinicians are using NMES as recommended by current TKA practice guidelines.

To address this gap, the investigators will conduct a cluster randomized trial in two healthcare systems (UCHealth and Intermountain Health) and their associated outpatient physical therapy clinics (n=30) to evaluate the effectiveness and implementation of NMES to address musculoskeletal deficits after TKA.

The investigators will compare outcomes between patients who receive contemporary rehabilitation supported by a comprehensive NMES implementation strategy (NMES) to patients who receive contemporary musculoskeletal rehabilitation alone (Usual Care; Aim 1). The investigators will gather information on NMES implementation to promote its uptake and translation to clinical practice (Aim 2).

Вмешательства

• Процедура NMES
  The NMES intervention protocol in this study ensures patients receive NMES intervention that is adequately dosed (dose = treatment minutes x intensity), delivered using evidence-based parameters, and feasible. The investigators will deliver NMES using a portable two-channel stimulator that the investigators have found to produce stronger muscle contractions than other portable NMES units and has been used in previous clinical studies. It also has a built-in compliance meter to monitor patient tr
• Другое Usual Care
  Usual Care clinics will continue with routine collection and documentation of physical performance outcomes as standard practice. A combination of chart reviews and on-site or remote observation will allow for characterization of usual care components for descriptive comparison. Usual Care clinics including the facility, rehabilitation clinicians, and patients will not have access to NMES materials developed for this study.

Первичные конечные точки

• Timed Up and Go (TUG) [Срок оценки: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks]

Вторичные конечные точки (7)

• 30 Second Sit-to-Stand (30-STS) [Срок оценки: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks]
• Quadriceps Strength [Срок оценки: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks]
• Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL) [Срок оценки: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks]
• Knee Range of Motion (ROM) [Срок оценки: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks]
• Visit Utilization [Срок оценки: Post-operative PT baseline up to 24 weeks]
• Patient Satisfaction [Срок оценки: Post-operative 6 weeks]
• NMES Satisfaction [Срок оценки: Post-operative 6 weeks]

Критерии участия

Критерии включения

Site Inclusion Criteria:

• UCHealth or Intermountain Health outpatient physical therapy clinic

Patient Inclusion Criteria:

• Underwent primary unilateral TKA
• Attended outpatient rehabilitation at a participating clinic within 5 days after TKA
• Attended at least 3 total outpatient physical therapy visits in total

Критерии исключения

Patient Exclusion Criteria:

• NMES Contraindications \[Patients with implanted cardiovascular cardiovertedefibrillator (ICD), active cancer, post-operative diagnosed deep vein thrombosis (DVT) in involved lower extremity\]
• Previous lower extremity arthroplasty less than 12 weeks prior to scheduled TKA surgical date

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• UCHealth — Aurora
• University of Colorado Denver, Anschutz — Aurora
• Intermountain Health — Murray

Идентификаторы

NCT: NCT06953375 · 24-0868 · R01AG084683

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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