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Comparative Clinical and Economic Evaluation of Three Minimally Invasive Procedures for Lumbar Disc Herniation: A Multicenter Randomized Controlled Trial

Comparative Clinical and Economic Evaluation of Three Minimally Invasive Procedures for Lumbar Disc Herniation: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113777
Enrollment
Unknown
Registered
2025-12-03
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar disc herniation

Interventions

Sponsors

The Seventh Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients who meet the diagnostic criteria and surgical indications of the "Diagnosis and Treatment Guidelines for Lumbar Intervertebral Disc Herniation" published in the Chinese Journal of Orthopedics in 2020, and also meet the following conditions: 1. Age >= 18 years old 2. Symptoms: Radiation radicular pain, muscle weakness and/or sensory abnormalities in the innervated area of the affected nerve roots, with or without low back pain. 3. Physical signs: motor and/or sensory disorders innervated by affected nerve roots, with or without decreased tendon reflexes; Positive nerve pull test, such as Lasegue sign test, contralateral Lasegue sign test, femoral nerve pull test, etc; With or without local lumbar tenderness and limited mobility. 4. Lumbar MRI confirms that the segment of lumbar disc herniation is consistent with symptoms and signs. 5. The medical history exceeds 6-12 weeks and systematic conservative treatment is ineffective; During conservative treatment, symptoms are getting worsen or recur, affecting work or life. 6. The type of lumbar disc herniation is paramedian.

Exclusion criteria

Exclusion criteria: 1. Previous lumbar surgery at the same level or adjacent level; 2. Cauda equina syndrome; 3. Pregnancy; 4. Serious underlying diseases (ASA > 2); 5. The disc fragment was more than half the height of the adjacent vertebral body to the head or tail end; 6. The classification of lumbar disc herniation was central type and extreme lateral type. 7. Surgery for two or more herniated discs; 8. Combined with lumbar instability, spinal tumors, spinal fractures, and ankylosing spondylitis; 9. Mental illness or cognitive impairment, communication difficulties and inability to complete the questionnaire; 10. There are surgical contraindications, such as systemic or local active infection, coagulopathy, etc. 11. Refusal to sign informed consent.

Design outcomes

Primary

MeasureTime frame
Oswestry disability index;

Secondary

MeasureTime frame
Visual analogue scale leg pain;Visual analogue scale back pain;Short form 36 health survey questionnaire;Operative time;Intraoperative bleeding;Hospitalization days;Lumbar surgical segment stability;Changes in the area of lumbar paravertebral muscles;Degree of fat formation in lumbar paravertebral muscles;Total hospitalization expenses;Cost of surgery;Cost of consumable material;Return to work time;

Countries

China

Contacts

Public ContactFuxin Wei

The Seventh Affiliated Hospital of Sun Yat-sen University

weifuxin@mail.sysu.edu.cn+86 135 6017 0686

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026