Lumbar Disc HerniationNCT07161232
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
A study testing Standardized Postoperative Rehabilitation Protocol in people with Lumbar Disc Herniation and Postoperative Rehabilitation, run by Li Xiang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation, Postoperative Rehabilitation
- What is being tested?
- Standardized Postoperative Rehabilitation Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2025to 28 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Yue Li, +86 10 63139006, 13661202501@163.com
About this study
Official title: The Influence of the Timing of Postoperative Rehabilitation Intervention on the Clinical
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.
Read the 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.
- Being tested
- Standardized Postoperative Rehabilitation Protocol
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Postoperative Rehabilitation ProtocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standardized Postoperative Rehabilitation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start28 Mar 2025
- Primary completion28 Nov 2026 (estimated)
- Study completion28 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Xiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Xiang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161232
- Sponsor's protocol ID
- 2025-P2-070-02
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Timing of Postoperative Rehabilitation Intervention on the Clinical
- ClinicalTrials.gov ID
- NCT07161232
- Acronym / sponsor ID
- 2025-P2-070-02
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Li XiangUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 28 Nov 2026 (estimated)
- Study completion
- 28 Mar 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Rehabilitation Group | Experimental | Behavioral: Standardized Postoperative Rehabilitation ProtocolPatients 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. |
| Late Rehabilitation Group | Active comparator | Behavioral: Standardized Postoperative Rehabilitation ProtocolThis 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Postoperative Rehabilitation ProtocolThis 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. | Behavioural | Early Rehabilitation Group, Late Rehabilitation Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Postoperative Rehabilitation Protocol in people with Lumbar Disc Herniation and Postoperative Rehabilitation, run by Li Xiang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) Score (time frame: Change from Baseline to 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.