The Influence of the Timing of Postoperative Rehabilitation Intervention on the Clinical Efficacy of Unilateral Biportal Endoscopic Spine System in the Treatment of Lumbar Disc Herniation

NCT07161232 | Recruiting

• 1 other identifier: 2025-P2-070-02
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study focuses on the impact of the timing of postoperative rehabilitation intervention on the clinical efficacy of unilateral biportal endoscopic spine surgery in the treatment of lumbar disc herniation. The main objective is to explore this impact and provide high-quality evidence-based medical evidence for making reasonable clinical decisions.

Conditions

Lumbar Disc Herniation; Postoperative Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (ODI) Score

  The Oswestry Disability Index (ODI) is a widely validated and disease-specific patient-reported outcome measure for assessing functional status in individuals with low back pain. The questionnaire consists of 10 items addressing pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment/homemaking. Each item is scored from 0 to 5, and the total score is converted to a percentage (0-100%), with higher scores indicating greater disability. The ODI score at 12 months postoperatively will be used as the primary endpoint to evaluate the long-term effect of rehabilitation timing.

  Change from Baseline to 12 months postoperatively

Study Arms (2)

Early Rehabilitation Group

EXPERIMENTAL

Patients in this arm will commence a standardized, progressive rehabilitation program at 2 weeks (±3 days) following unilateral biportal endoscopic (UBE) surgery. The regimen consists of core stability exercises and neurodynamic techniques designed to early activate core muscles, prevent neural adhesion, and restore function. Specific exercises include transverse abdominis activation, sit-to-stand training with abdominal bracing, four-point kneeling rockbacks for spinal mobility, neural mobilization in the modified straight leg raise position, and neural sliding techniques. The exercises are performed once daily and progressed based on patient tolerance. The entire intervention is supervised by a senior physical therapist.

Behavioral: Standardized Postoperative Rehabilitation Protocol

Late Rehabilitation Group

ACTIVE COMPARATOR

This arm serves as the active comparator. Patients will commence the identical standardized, progressive rehabilitation program as the Experimental arm at 6 weeks (±3 days) following unilateral biportal endoscopic (UBE) surgery. The content of the rehabilitation regimen, exercise frequency, progression criteria, and supervision by a physical therapist are exactly the same as in the Experimental arm. This timing represents the conventional, later postoperative rehabilitation approach.

Behavioral: Standardized Postoperative Rehabilitation Protocol

Interventions

Standardized Postoperative Rehabilitation Protocol BEHAVIORAL

This intervention is a standardized, progressive rehabilitation protocol for patients after lumbar disc herniation surgery, delivered under the guidance of a senior physical therapist. The protocol aims to improve pain, restore function, and prevent complications through core stability exercises and neurodynamic techniques. The exercises are performed once daily and progressed based on patient tolerance. The protocol consists of two phases: Initial Phase ( commencing postoperatively): Includes: 1) Transverse abdominis activation; 2) Sit-to-stand training with abdominal bracing; 3) Four-point kneeling rockbacks for spinal mobility; 4) Neural mobilization techniques (performed in sitting); 5) Neural sliding techniques (performed in sitting). Progressive Phase: Builds upon the initial exercises by increasing the range of motion, adding isometric hold times, and integrating cervical movement with neural techniques to increase difficulty and intensity.

Early Rehabilitation Group; Late Rehabilitation Group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 19 and 65 years.
• Diagnosed with lumbar disc herniation by imaging and scheduled for unilateral biportal endoscopic (UBE) surgery.
• Presenting with radicular pain in the lower extremity, with a history of less than 1 year.
• Able to understand Chinese and complete questionnaires independently.
• Physically capable of participating in exercise rehabilitation.
• Willing to participate and provide written informed consent.

You may not qualify if:

• Aged under 18 or over 65 years.
• Combined with other spinal pathologies (e.g., ankylosing spondylitis, rheumatoid arthritis, spinal tumor, spinal fracture, cauda equina syndrome).
• Diagnosis of neurological disorders (e.g., multiple sclerosis, Parkinson's disease).
• Presence of uncontrolled cardiovascular, respiratory, or peripheral vascular diseases.
• History of severe psychiatric disorders (e.g., schizophrenia).
• Previous history of spinal surgery.
• Pregnancy or lactation.
• Inability to understand or comply with the study procedures.

Sponsors & Collaborators

• Li Xiang: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 8, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): November 28, 2026
• Study Completion (Estimated): March 28, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)