Comparison Of Early Mobilization And Electrical Stimulation On Functional Recovery After Lumbar Disc Herniation Surgery

Официальное название

Comparison Of Early Mobilization And Electrical Stimulation-Supported Rehabilitation On Functional Recovery, Pain Level, And Mobility After Lumbar Disc Herniation Surgery: A Prospective Randomized Controlled Trial

Обзор

This randomized controlled trial aims to compare the effectiveness of early mobilization alone versus early mobilization combined with electrical stimulation on functional recovery following lumbar disc herniation surgery. Lumbar disc herniation is a common cause of low back pain and functional limitation, significantly affecting quality of life. Although surgical intervention is effective in patients who do not respond to conservative treatment, optimal postoperative recovery largely depends on appropriate rehabilitation strategies. Early mobilization is widely recommended to prevent complications, preserve muscle function, and facilitate return to daily activities. In addition, electrical stimulation modalities such as neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS) have been increasingly integrated into rehabilitation programs to enhance pain control, muscle activation, and neuromuscular re-education. In this study, a total of 60 participants who have undergone primary lumbar disc herniation surgery will be randomly assigned into two groups. The first group will receive an early mobilization program alone, while the second group will receive early mobilization combined with electrical stimulation (NMES/TENS). The intervention period will last 6 to 8 weeks, with sessions conducted three times per week. Primary outcomes include functional disability measured by the Oswestry Disability Index (ODI) and pain intensity measured by the Visual Analog Scale (VAS). Secondary outcomes include functional mobility assessed by the Timed Up and Go (TUG) test, walking speed assessed by the 10-Meter Walk Test (10MWT), and muscle strength evaluated using manual muscle testing (MMT). The findings of this study are expected to contribute to the development of evidence-based postoperative rehabilitation protocols and to clarify the clinical effectiveness of electrical stimulation in patients undergoing lumbar disc herniation surgery

Подробное описание

Lumbar disc herniation is one of the most prevalent musculoskeletal conditions leading to low back pain, disability, and reduced functional capacity in adults. Surgical treatment is commonly indicated in patients with persistent symptoms or neurological deficits who do not respond to conservative management. Despite successful surgical intervention, postoperative recovery outcomes vary considerably and are highly influenced by rehabilitation strategies.

Early mobilization is considered a cornerstone of postoperative rehabilitation, as it reduces the risk of complications such as deep vein thrombosis, muscle atrophy, and joint stiffness. It also promotes faster recovery of functional independence and return to daily activities. However, early mobilization alone may not be sufficient to optimize neuromuscular recovery and pain management in all patients.

Electrical stimulation modalities, including neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS), have been increasingly utilized in rehabilitation settings. NMES facilitates muscle activation and prevents disuse atrophy, while TENS is widely used for pain modulation through neurophysiological mechanisms such as gate control theory. These modalities may provide additional benefits when combined with conventional rehabilitation approaches.

However, there is a limited number of high-quality randomized controlled trials directly comparing early mobilization alone with electrical stimulation-supported rehabilitation in patients following lumbar disc herniation surgery. This gap in the literature highlights the need for well-designed clinical trials to guide evidence-based practice.

Study Design

This study is designed as a prospective, two-arm, parallel-group randomized controlled trial. Participants will be randomly allocated using a computer-generated randomization method into one of two groups:

Group 1: Early mobilization program Group 2: Early mobilization combined with electrical stimulation (NMES/TENS) Intervention Protocol Both groups will participate in a structured rehabilitation program conducted three times per week for 6-8 weeks. The early mobilization program will include gradual ambulation, posture training, range of motion exercises, and functional activity training.

In the intervention group, electrical stimulation will be applied to paraspinal and lower extremity muscle groups. The parameters of NMES and TENS will be adjusted based on patient tolerance and clinical indications.

Outcome Measures Assessments will be performed at baseline (pre-intervention) and after completion of the intervention program.

Primary Outcomes:

Functional disability: Oswestry Disability Index (ODI) Pain intensity: Visual Analog Scale (VAS)

Secondary Outcomes:

Functional mobility: Timed Up and Go (TUG) test Walking speed: 10-Meter Walk Test (10MWT) Muscle strength: Manual Muscle Testing (MMT) Eligibility Criteria Participants aged between 18 and 65 years who have undergone primary lumbar disc herniation surgery and are in the early postoperative period (within the first 2 weeks) will be included. Patients with previous spinal surgery, severe neurological deficits, contraindications to electrical stimulation (e.g., pacemaker), or serious systemic diseases will be excluded.

Statistical Analysis Data will be analyzed using IBM SPSS Statistics software. Normality will be assessed using the Shapiro-Wilk test. Between-group comparisons will be performed using independent samples t-test or Mann-Whitney U test, while within-group comparisons will be analyzed using paired samples t-test or Wilcoxon signed-rank test. A two-way repeated measures ANOVA will be used to evaluate group-by-time interactions. A p-value of less than 0.05 will be considered statistically significant.

Expected Outcomes and Significance This study aims to provide high-quality evidence regarding the comparative effectiveness of early mobilization and electrical stimulation-supported rehabilitation. The results are expected to support clinical decision-making, optimize postoperative rehabilitation protocols, and contribute to the advancement of evidence-based physiotherapy practices.

Вмешательства

• Другое Early Mobilization Program
  A structured early mobilization program initiated in the early postoperative period following lumbar disc herniation surgery. The program includes gradual ambulation, posture training, range of motion exercises, and functional activity training. Sessions will be conducted three times per week for 6-8 weeks. The program is designed to improve functional recovery, mobility, and independence in daily activities.
• Устройство Electrical Stimulation (NMES/TENS)
  Electrical stimulation will be applied as an adjunct to early mobilization in the postoperative rehabilitation of lumbar disc herniation. Neuromuscular electrical stimulation (NMES) will be used to facilitate muscle activation and prevent muscle atrophy, while transcutaneous electrical nerve stimulation (TENS) will be used for pain modulation. Stimulation will be applied to paraspinal and lower extremity muscle groups according to patient tolerance and clinical indications. Sessions will be cond

Первичные конечные точки

• Oswestry Disability Index (ODI) [Срок оценки: Baseline (pre-intervention) and 8 weeks post-intervention]
• Visual Analog Scale (VAS) for Pain [Срок оценки: Baseline (pre-intervention) and 8 weeks post-intervention]

Вторичные конечные точки (3)

• Timed Up and Go Test (TUG) [Срок оценки: Baseline and 8 weeks post-intervention]
• 10-Meter Walk Test (10MWT) [Срок оценки: Baseline and 8 weeks post-intervention]
• Manual Muscle Testing (MMT) [Срок оценки: Baseline and 8 weeks post-intervention]

Критерии участия

Критерии включения

• Age between 18 and 65 years
• Patients who have undergone primary lumbar disc herniation surgery
• Being in the early postoperative period (within the first 2 weeks after surgery)
• Clinically stable condition
• Ability to understand and follow instructions
• Willingness to participate in the study and provide informed consent

Критерии исключения

• History of previous spinal surgery
• Presence of severe neurological deficits (e.g., progressive motor loss, cauda equina syndrome)
• Contraindications to electrical stimulation (e.g., pacemaker, implanted electronic devices)
• Presence of severe systemic or uncontrolled chronic diseases (e.g., severe cardiovascular, respiratory, or metabolic disorders)
• Cognitive impairment or inability to cooperate with rehabilitation program Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07575477 · LDH-EMES-2026 · Medipol-PT-2026-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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