Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07741162

Paraspinal NMES and Spinopelvic Alignment After Knee Arthroplasty

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Postoperative Rehabilitation Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Location contact

Sinem Akselim

CONTACT

[email protected]

+905336391332

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Standard Postoperative Rehabilitation Program

Other

A structured rehabilitation program including early postoperative mobilization (days 1-3: standing, short-distance ambulation, quadriceps isometric exercises, ankle pumping, breathing exercises, cold application), pre-rehabilitation phase (days 4-15: assisted ambulation, straight leg raise, passive range-of-motion exercises), and active rehabilitation phase (weeks 2-3: active-assisted knee ROM exercises, closed kinetic chain exercises, balance training, stair and gait training), along with pain and edema control throughout.

Quadriceps Neuromuscular Electrical Stimulation

Device

Surface NMES applied bilaterally over the vastus medialis obliquus and rectus femoris muscles (long-sitting position, knee at 30° flexion). Parameters: 50 Hz frequency, 300-400 µs pulse width, duty cycle 1:3 (10 sec on-30 sec off), intensity titrated to patient tolerance to produce visible muscle contraction, 20 minutes/session, once daily, 5 days/week, for 4 weeks.

Other names: Chattanooga Physio NMES device

Paraspinal Neuromuscular Electrical Stimulation

Device

Surface NMES applied bilaterally to the lumbar paraspinal muscles (erector spinae and multifidus) via 4 hydrogel electrodes placed bilaterally around the L4-L5 spinous processes, in prone position. Parameters: 50 Hz frequency, 250-350 µs pulse width, duty cycle 1:3 (10 sec on-30 sec off), intensity titrated to patient tolerance to produce visible muscle contraction, 20 minutes/session, once daily, 5 days/week, for 4 weeks.

Other names: Chattanooga Physio NMES device

Primary outcomes

  1. Change from Baseline in Pelvic Tilt (PT)

    Time frame: 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

  2. Change from Baseline in Sagittal Vertical Axis (SVA)

    Time frame: 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

  3. Change from Baseline in Radiographic Spinopelvic Angular Parameters (Sacral Slope, Lumbar Lordosis, Spinosacral Angle)

    Time frame: 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

Secondary outcomes

  1. Change from Baseline in Knee Pain (Visual Analog Scale)

    Time frame: 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)

    Knee pain will be assessed using a 0-10 cm Visual Analog Scale, with scores ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate greater pain intensity.

    Unit of Measure: score on a scale (0-10)

  2. Change from Baseline in Low Back Pain (Visual Analog Scale)

    Time frame: 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)

    Low back pain will be assessed using a 0-10 cm Visual Analog Scale, with scores ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate greater pain intensity.

    Unit of Measure: score on a scale (0-10)

  3. Change from Baseline in WOMAC Osteoarthritis Index Score

    Time frame: Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)

    Knee-related pain, stiffness, and physical function will be assessed using the Turkish-validated WOMAC index, with a total score ranging from 0 to 96; higher scores indicate greater symptom severity and worse function.

    Unit of Measure: score on a scale

  4. Change from Baseline in Knee Society Score (KSS)

    Time frame: 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)

    Knee pain, range of motion, and functional status will be assessed using the Knee Society Score, comprising a knee score and a function score, each ranging from 0 to 100; higher scores indicate better knee status and function.

    Unit of Measure: score on a scale

  5. Change from Baseline in Forgotten Joint Score (FJS)

    Time frame: 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)

    Awareness of the artificial joint during daily activities will be assessed using the FJS, with scores ranging from 0 to 100; higher scores indicate lower joint awareness, reflecting a better outcome.

    Unit of Measure: score on a scale (0-100)

  6. Change from Baseline in Timed Up and Go (TUG) Test

    Time frame: Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)

    Functional mobility will be assessed using the TUG test, measuring the time required to stand up from a chair, walk 3 meters, turn, return, and sit down. Higher times indicate poorer mobility.

    Unit of Measure: seconds

  7. Change from Baseline in 6-Minute Walk Test Distance

    Time frame: Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)

    Aerobic capacity and functional endurance will be assessed using the distance walked in 6 minutes. Greater distance indicates better functional capacity.

    Unit of Measure: meters

  8. Change from Baseline in Oswestry Disability Index

    Time frame: Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), postoperative month 3 (T3), and 6-month follow-up (T4)

    Low back function-related disability will be assessed using the Turkish-validated Oswestry Disability Index, with scores ranging from 0% to 100%; higher scores indicate greater disability.

    Unit of Measure: percentage

  9. Change from Baseline in Nottingham Health Profile

    Time frame: Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), and 6-month follow-up (T4)

    General health-related quality of life will be assessed using the Turkish-validated Nottingham Health Profile.

    Unit of Measure: score on a scale

Study contacts

Contact information is provided by the study sponsor or research team.

Sinem Akselim

CONTACT

[email protected]

+905336391332

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Effect of Paraspinal Neuromuscular Electrical Stimulation Added to Rehabilitation Program on Spinopelvic Alignment Parameters After Total Knee Arthroplasty: A Prospective Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.