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

NCT ID: NCT07161232

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-28
• Study Completion Date: 2027-03-28

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.

Detailed Description

This study is a prospective randomized controlled trial 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 purpose is to explore this impact and provide high-quality evidence-based medical evidence for making reasonable clinical decisions. According to the inclusion and exclusion criteria formulated in this study, 72 patients who underwent UBE surgery for lumbar disc herniation were recruited in our hospital and randomly assigned to the early rehabilitation intervention group (referred to as the early rehabilitation group, with rehabilitation intervention starting 2 weeks after surgery) or the late rehabilitation intervention group (referred to as the late rehabilitation group, with rehabilitation intervention starting 6 weeks after surgery) after surgery. The clinical and subjective (questionnaire) data of the subjects before surgery, after surgery and during the follow-up process (up to 12 months after surgery) were collected to compare the differences in clinical efficacy between early and late postoperative rehabilitation intervention in patients with lumbar disc herniation treated by UBE.

Conditions

Lumbar Disc Herniation; Postoperative Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Rehabilitation Group

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.

Group Type: EXPERIMENTAL

Standardized Postoperative Rehabilitation Protocol

Intervention Type: 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.

Late Rehabilitation Group

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.

Group Type: ACTIVE_COMPARATOR

Standardized Postoperative Rehabilitation Protocol

Intervention Type: 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.

Interventions

Standardized Postoperative Rehabilitation Protocol

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Li Xiang

OTHER

Sponsor Role: lead

Responsible Party

Li Xiang

chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yue Li

Role: primary

13661202501@163.com

+86 10 63139006

Other Identifiers

2025-P2-070-02

Identifier Type: -

Identifier Source: org_study_id