Paraspinal NMES and Spinopelvic Alignment After Knee Arthroplasty

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Conditions studied: Knee Osteoarthritis, Postoperative Rehabilitation

In brief

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.

Key facts

Study ID: NCT07741162
Run by: Bursa Yuksek Ihtisas Training and Research Hospital
People needed: 80
Starts: 2026-07-30
Expected to finish: 2027-07-30
Last updated by the study team: 2026-08-03

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital — Bursa, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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