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NCT Number: NCT07161232

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

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.

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Rehabilitation Spinal Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location status: Recruiting

Location contact

Yue Li

CONTACT

[email protected]

+86 10 63139006

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Oswestry Disability Index (ODI) Score

Time frame: Change from Baseline to 12 months postoperatively

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.

Sponsors and collaborators

Lead sponsor

Li Xiang

Other

Registry information

Official study title

The Influence of the Timing of Postoperative Rehabilitation Intervention on the Clinical

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Sep 8, 2025
Registry last updated: Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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