Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT07161232
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-03-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-30', 'studyFirstSubmitDate': '2025-08-30', 'studyFirstSubmitQcDate': '2025-08-30', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI) Score', 'timeFrame': 'Change from Baseline to 12 months postoperatively', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Disc Herniation', 'Postoperative Rehabilitation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged between 19 and 65 years.\n\nDiagnosed with lumbar disc herniation by imaging and scheduled for unilateral biportal endoscopic (UBE) surgery.\n\nPresenting with radicular pain in the lower extremity, with a history of less than 1 year.\n\nAble to understand Chinese and complete questionnaires independently.\n\nPhysically capable of participating in exercise rehabilitation.\n\nWilling to participate and provide written informed consent.\n\nExclusion Criteria:\n\n* Aged under 18 or over 65 years.\n\nCombined with other spinal pathologies (e.g., ankylosing spondylitis, rheumatoid arthritis, spinal tumor, spinal fracture, cauda equina syndrome).\n\nDiagnosis of neurological disorders (e.g., multiple sclerosis, Parkinson's disease).\n\nPresence of uncontrolled cardiovascular, respiratory, or peripheral vascular diseases.\n\nHistory of severe psychiatric disorders (e.g., schizophrenia).\n\nPrevious history of spinal surgery.\n\nPregnancy or lactation.\n\nInability to understand or comply with the study procedures."}, 'identificationModule': {'nctId': 'NCT07161232', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'The Influence of the Timing of Postoperative Rehabilitation Intervention on the Clinical', 'orgStudyIdInfo': {'id': '2025-P2-070-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Rehabilitation Group', 'description': '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.', 'interventionNames': ['Behavioral: Standardized Postoperative Rehabilitation Protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Late Rehabilitation Group', 'description': '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.', 'interventionNames': ['Behavioral: Standardized Postoperative Rehabilitation Protocol']}], 'interventions': [{'name': 'Standardized Postoperative Rehabilitation Protocol', 'type': 'BEHAVIORAL', 'description': '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:\n\nInitial 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).\n\nProgressive 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.', 'armGroupLabels': ['Early Rehabilitation Group', 'Late Rehabilitation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yue Li', 'role': 'CONTACT', 'email': '13661202501@163.com', 'phone': '+86 10 63139006'}], 'facility': 'Beijing Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The ethical approval and patient informed consent forms obtained for this study are applicable only for the current research objectives and do not include provisions for public sharing of individual data. To protect patient privacy and comply with ethical regulations, we are unable to publicly share IPD at this time.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Li Xiang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Li Xiang', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}