Effect of Paraspinal Neuromuscular Electrical Stimulation Added to Rehabilitation Program on Spinopelvic Alignment Parameters After Total Knee Arthroplasty: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from Baseline in Pelvic Tilt (PT)
研究概览
简要总结
Total knee arthroplasty (TKA) is a widely performed surgical procedure for patients with severe knee osteoarthritis. Following TKA, changes in lower extremity alignment and gait mechanics may influence the spinopelvic sagittal alignment, and postoperative rehabilitation programs traditionally focus on the knee joint without addressing the lumbopelvic chain.
This study aims to investigate whether adding paraspinal neuromuscular electrical stimulation (NMES) to a standard postoperative rehabilitation program (which includes quadriceps NMES) affects spinopelvic sagittal alignment parameters in patients undergoing TKA for primary knee osteoarthritis, compared with standard rehabilitation and quadriceps NMES alone.
In this single-center, prospective, randomized, single-blind (outcome assessor-blinded) controlled trial, eligible participants aged 40-80 years with primary knee osteoarthritis scheduled for TKA and with measurable spinopelvic malalignment will be randomly assigned in a 1:1 ratio to receive either standard rehabilitation with quadriceps NMES plus paraspinal NMES (intervention group) or standard rehabilitation with quadriceps NMES alone (control group) for 4 weeks (20 sessions).
The primary outcome is the change in radiographic spinopelvic parameters - including pelvic tilt, sacral slope, pelvic incidence, lumbar lordosis, sagittal vertical axis, and spinosacral angle - measured on standing lateral whole-spine radiographs at baseline (preoperative), before rehabilitation, after the 4-week intervention, and at 6-month follow-up. Secondary outcomes include knee and back pain (VAS), functional and quality-of-life measures (WOMAC, Knee Society Score, Forgotten Joint Score, Oswestry Disability Index, Nottingham Health Profile), performance-based tests (Timed Up and Go, 6-Minute Walk Test), and knee range of motion.
The investigators hypothesize that adding paraspinal NMES to standard rehabilitation will result in greater improvement in spinopelvic alignment parameters, and potentially in clinical/functional outcomes, compared with standard rehabilitation alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 80 years
- •Diagnosis of primary knee osteoarthritis scheduled for total knee arthroplasty
- •Radiographic evidence of Kellgren-Lawrence grade 3-4 knee osteoarthritis
- •Preoperative knee flexion contracture ≥ 5°
- •Measurable spinopelvic malalignment, defined as meeting at least one of the following criteria: pelvic tilt (PT) > 20°, sagittal vertical axis (SVA) > 50 mm, or lumbar lordosis (LL) < 40°
- •IIntact cognitive function based on clinical judgment, sufficient to understand and follow verbal commands, cooperate with the rehabilitation program, and reliably comply with functional assessment procedures
- •Provision of written informed consent
- •Able to stand independently and undergo standing lateral radiography
排除标准
- •Prior lumbar or thoracic spinal surgery
- •History of hip arthroplasty
- •Prior knee arthroplasty (revision arthroplasty patients)
- •Active inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis)
- •Neurological disease, including stroke, Parkinson's disease, peripheral neuropathy, or spinal cord pathology
- •Contraindications to NMES, including active cardiac pacemaker, implanted defibrillator, deep vein thrombosis, skin integrity impairment, malignancy, or epilepsy
- •Severe hip osteoarthritis or other lower extremity pathology significantly affecting spinopelvic alignment (e.g., leg length discrepancy, developmental hip dysplasia, contracture)
- •Inability to complete the standard rehabilitation protocol due to postoperative complications
- •Osteoporotic vertebral fracture or significant osteoporosis (T-score < -2.5 at L1-L4)
- •Active treatment for malignancy
- •Psychiatric or medical condition that would prevent completion of the follow-up period
- •General contraindications to exercise
研究组 & 干预措施
Experimental: Intervention Group
Standard Rehabilitasyon + Quadriceps NMES + Paraspinal NMES Description: Participants in this arm will receive the standard postoperative rehabilitation program combined with quadriceps NMES, plus additional paraspinal (erector spinae and multifidus) NMES applied bilaterally over the L4-L5 region for 20 minutes/day, 5 days/week, for 4 weeks.
干预措施: Quadriceps Neuromuscular Electrical Stimulation (Device)
Active Comparator: Control Group
Standard Rehabilitasyon + Quadriceps NMES Description: Participants in this arm will receive the same standard postoperative rehabilitation program combined with quadriceps NMES (bilateral VMO and rectus femoris electrode placement) for 20 minutes/day, 5 days/week, for 4 weeks, without paraspinal NMES.
干预措施: Standard Postoperative Rehabilitation Program (Other)
Experimental: Intervention Group
Standard Rehabilitasyon + Quadriceps NMES + Paraspinal NMES Description: Participants in this arm will receive the standard postoperative rehabilitation program combined with quadriceps NMES, plus additional paraspinal (erector spinae and multifidus) NMES applied bilaterally over the L4-L5 region for 20 minutes/day, 5 days/week, for 4 weeks.
干预措施: Standard Postoperative Rehabilitation Program (Other)
Active Comparator: Control Group
Standard Rehabilitasyon + Quadriceps NMES Description: Participants in this arm will receive the same standard postoperative rehabilitation program combined with quadriceps NMES (bilateral VMO and rectus femoris electrode placement) for 20 minutes/day, 5 days/week, for 4 weeks, without paraspinal NMES.
干预措施: Quadriceps Neuromuscular Electrical Stimulation (Device)
Experimental: Intervention Group
Standard Rehabilitasyon + Quadriceps NMES + Paraspinal NMES Description: Participants in this arm will receive the standard postoperative rehabilitation program combined with quadriceps NMES, plus additional paraspinal (erector spinae and multifidus) NMES applied bilaterally over the L4-L5 region for 20 minutes/day, 5 days/week, for 4 weeks.
干预措施: Paraspinal Neuromuscular Electrical Stimulation (Device)
结局指标
主要结局
Change from Baseline in Pelvic Tilt (PT)
时间窗: Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), and 6-month follow-up (T4)
Pelvic tilt will be measured as the angle between the line connecting the midpoint of the sacral plate to the center of the femoral head axis and the vertical line, assessed on standing lateral whole-spine radiographs (36-inch cassette) by two independent physicians blinded to group allocation. Measurements will be performed using PACS-integrated measurement software. Interobserver reliability (ICC ≥ 0.85) and intraobserver reliability (repeat measurement at 2-week interval) will be assessed. Unit of Measure: degrees
Change from Baseline in Sagittal Vertical Axis (SVA)
时间窗: Baseline (T0), before rehabilitation (T1), end of 4-week intervention (T2), and 6-month follow-up (T4)
The horizontal distance between the C7 plumb line and the posterosuperior corner of S1 will be measured on standing lateral whole-spine radiographs. Unit of Measure: millimeters
Change from Baseline in Radiographic Spinopelvic Angular Parameters (Sacral Slope, Lumbar Lordosis, Spinosacral Angle)
时间窗: Baseline (T0), before rehabilitation (T1), end of 4-week intervention (T2), and 6-month follow-up (T4)
Sacral slope (angle between the S1 superior endplate and horizontal), lumbar lordosis (Cobb angle between L1 and S1), and spinosacral angle (angle between the line connecting the C7 center to the sacral plate midpoint and the sacral plate) will be measured on the same standing lateral whole-spine radiographs described above. Unit of Measure: degrees
次要结局
- Change from Baseline in Knee Pain (Visual Analog Scale)(Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4))
- Change from Baseline in Low Back Pain (Visual Analog Scale)(Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4))
- Change from Baseline in WOMAC Osteoarthritis Index Score(Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4))
- Change from Baseline in Knee Society Score (KSS)(Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4))
- Change from Baseline in Forgotten Joint Score (FJS)(Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4))
- Change from Baseline in Timed Up and Go (TUG) Test(Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4))
- Change from Baseline in 6-Minute Walk Test Distance(Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4))
- Change from Baseline in Oswestry Disability Index(Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4))
- Change from Baseline in Nottingham Health Profile(Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), and 6-month follow-up (T4))
研究者
Sinem Akselim
Principle investigator
Bursa Yuksek Ihtisas Training and Research Hospital