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Paraspinal NMES and Spinopelvic Alignment After Knee Arthroplasty

27 juillet 2026 mis à jour par: Sinem Akselim, Bursa Yuksek Ihtisas Training and Research Hospital

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

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

80

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Turquie (Türkiye)
      • Bursa, Turquie (Türkiye)
        • University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: Standard Postoperative Rehabilitation Program
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.
Dispositif: Quadriceps Neuromuscular Electrical Stimulation
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.
Autres noms:
  • Chattanooga Physio NMES device
Dispositif: Paraspinal Neuromuscular Electrical Stimulation
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.
Autres noms:
  • Chattanooga Physio NMES device
Comparateur actif: 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.
Autre: Standard Postoperative Rehabilitation Program
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.
Dispositif: Quadriceps Neuromuscular Electrical Stimulation
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.
Autres noms:
  • Chattanooga Physio NMES device

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from Baseline in Pelvic Tilt (PT)
Délai: 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
Baseline (preoperative, T0), before rehabilitation (postoperative, T1), end of 4-week intervention (postoperative week 6, T2), and 6-month follow-up (T4)
Change from Baseline in Sagittal Vertical Axis (SVA)
Délai: 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
Baseline (T0), before rehabilitation (T1), end of 4-week intervention (T2), and 6-month follow-up (T4)
Change from Baseline in Radiographic Spinopelvic Angular Parameters (Sacral Slope, Lumbar Lordosis, Spinosacral Angle)
Délai: 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
Baseline (T0), before rehabilitation (T1), end of 4-week intervention (T2), and 6-month follow-up (T4)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from Baseline in Knee Pain (Visual Analog Scale)
Délai: 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)
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)
Délai: 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)
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
Délai: 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
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)
Délai: 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
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)
Délai: 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)
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
Délai: 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
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
Délai: 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
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
Délai: 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
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
Délai: 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
Baseline (preoperative, T0), end of 4-week intervention (postoperative week 6, T2), and 6-month follow-up (T4)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Bursa Yuksek Ihtisas Training and Research Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

30 juillet 2026

Achèvement primaire (Estimé)

30 juillet 2027

Achèvement de l'étude (Estimé)

30 juillet 2027

Dates d'inscription aux études

Première soumission

23 juillet 2026

Première soumission répondant aux critères de contrôle qualité

27 juillet 2026

Première publication (Réel)

3 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026-9/11

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NON

Informations sur les médicaments et les dispositifs, documents d'étude

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Étudie un produit d'appareil réglementé par la FDA américaine

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