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Paraspinal NMES and Spinopelvic Alignment After Knee Arthroplasty

Key facts

Who runs it
Bursa Yuksek Ihtisas Training and Research Hospital
Where
Bursa, TürkiyeSee the site
Trial code
Status
Not yet recruiting
People taking part
80 people, planned
Started
30 Sept 2026
Expected to end
30 Jul 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Standard Postoperative Rehabilitation Program
  • Quadriceps Neuromuscular Electrical Stimulation
  • Paraspinal Neuromuscular Electrical Stimulation
Record updated
29 September 2026

Who can take part

Age
40 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Prior lumbar or thoracic spinal surgery
  • Prior knee arthroplasty (revision arthroplasty patients)
  • History of hip arthroplasty
  • 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
  • Active treatment for malignancy
  • Psychiatric or medical condition that would prevent completion of the follow-up period
  • Active inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis)
  • 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)
  • General contraindications to exercise

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 80 years old?

Where in Türkiye

  • University of Health Sciences Bursa Yuksek Ihtisas Training and Research HospitalBursa, TürkiyeContact: Sinem AkselimNo longer taking part

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • Experimental: Intervention GroupTreatment being tested

    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.

    Treatment: Standard Postoperative Rehabilitation Program, Quadriceps Neuromuscular Electrical Stimulation, and Paraspinal Neuromuscular Electrical Stimulation

  • Active Comparator: Control GroupExisting treatment, for comparison

    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.

    Treatment: Standard Postoperative Rehabilitation Program and Quadriceps Neuromuscular Electrical Stimulation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effect of Paraspinal Neuromuscular Electrical Stimulation Added to Rehabilitation Program on Spinopelvic Alignment Parameters After Total Knee Arthroplasty: A Prospective Randomized Controlled Trial
Fit questions
Built from NCT07741162, who can take part
Record updated
29 September 2026