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

NCT07575477 | Not Yet Recruiting

• 2 other identifiers: LDH-EMES-2026Medipol-PT-2026-05
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Lumbar Disc Herniation; Low Back Pain; Postoperative Rehabilitation

Keywords

Lumbar Surgery; Early Mobilization; Electrical Stimulation; Physiotherapy; Functional Recovery

Outcome Measures

Primary Outcomes (2)

• Oswestry Disability Index (ODI)

  The Oswestry Disability Index (ODI) will be used to evaluate functional disability related to low back pain following lumbar disc herniation surgery. The questionnaire consists of 10 sections assessing activities of daily living including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, and traveling. Each section is scored from 0 to 5, and total scores are expressed as a percentage, with higher scores indicating greater disability.

  Baseline (pre-intervention) and 8 weeks post-intervention

• Visual Analog Scale (VAS) for Pain

  Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10 cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will mark their perceived pain level. The VAS is widely used for both acute and chronic pain assessment and is highly sensitive to clinical change.

  Baseline (pre-intervention) and 8 weeks post-intervention

Secondary Outcomes (3)

• Timed Up and Go Test (TUG)

  Baseline and 8 weeks post-intervention

• 10-Meter Walk Test (10MWT)

  Baseline and 8 weeks post-intervention

• Manual Muscle Testing (MMT)

  Baseline and 8 weeks post-intervention

Study Arms (2)

Early Mobilization

ACTIVE COMPARATOR

Participants in this group will receive a structured early mobilization program following lumbar disc herniation surgery. The program will include gradual ambulation, posture training, range of motion exercises, and functional activity training. Sessions will be conducted three times per week for 6-8 weeks. No electrical stimulation will be applied in this group.

Other: Early Mobilization Program

Early Mobilization + Electrical Stimulation

EXPERIMENTAL

Participants in this group will receive the same early mobilization program combined with electrical stimulation (NMES and/or TENS). Electrical stimulation will be applied to paraspinal and lower extremity muscle groups based on patient tolerance and clinical indications. The rehabilitation program will be conducted three times per week for 6-8 weeks.

Other: Early Mobilization Program

Interventions

Early Mobilization Program OTHER

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.

Early Mobilization; Early Mobilization + Electrical Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

MeSH Terms

Conditions

Intervertebral Disc Displacement; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Mehmet Salih TAN, Doctorate

CONTACT

+905467266876; mstan@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group allocation to minimize assessment bias. Due to the nature of the interventions, participants and care providers cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Istanbul Medipol University

Model Details: Participants will be randomly assigned to one of two parallel 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). Both interventions will be applied over a period of 6-8 weeks, with sessions conducted three times per week. Outcomes will be assessed at baseline and post-intervention.

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05