Lumbar Degenerative Disease, Lumbar Radiculopathy, Sciatic Leg Pain, Sciatic Nerve Compression, Discopathy, Disc Herniation, Disc Herniation With Radiculopathy
Conditions
Brief summary
The goal of this clinical trial is to compare the clinical effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD) in patients aged 18-85 with single-level lumbar disc herniation who have not undergone prior lumbar surgery. This study also aims to perform a radiological analysis of MRI scans before and after treatment to optimize patient selection and surgical strategies. The main questions it aims to answer are: * Does FELD provide superior early postoperative pain relief (measured by VAS) compared to MD? * Does FELD offer better functional recovery (measured by COMI and ODI scores) postoperatively compared to MD? * Can radiological analysis of pre- and post-operative MRI images help optimize patient qualification and guide surgical strategies? Researchers will compare patients undergoing FELD to those undergoing MD to see if endoscopic techniques result in faster recovery and lower early postoperative pain while maintaining similar long-term outcomes. The study will also analyze how MRI findings correlate with clinical outcomes to refine operative decision-making. Participants will: * Undergo either FELD or MD surgery * Complete VAS, COMI, and ODI questionnaires at pre-specified follow-up intervals (1, 3, 6, and 12 months post-surgery) * Have MRI scans 24 hours before surgery, 24 hours after surgery, and at each follow-up to assess disc recurrence, residual pathology, and to optimize surgical strategies.
Interventions
FELD is a minimally invasive spine surgery technique performed through small incisions using an endoscope. The procedure involves accessing the herniated disc through either the transforaminal (TELD) or interlaminar (IELD) approach, depending on the location of the disc herniation. The endoscopic approach allows for direct visualization of the affected area using a camera, and specialized instruments are used to remove the herniated portion of the disc. What distinguishes this intervention: * Small incisions (typically <1 cm) result in less soft tissue damage compared to traditional open surgery. * Real-time endoscopic visualization allows for precise disc removal and reduced trauma to surrounding structures such as muscles and ligaments. * Minimized postoperative pain and faster recovery times due to the less invasive nature of the procedure. * Outpatient or short hospital stay is often possible, contributing to faster patient discharge.
PROCEDUREInterlaminar endoscopic lumbar discectomy
FELD is a minimally invasive spine surgery technique performed through small incisions using an endoscope. The procedure involves accessing the herniated disc through either the transforaminal (TELD) or interlaminar (IELD) approach, depending on the location of the disc herniation. The endoscopic approach allows for direct visualization of the affected area using a camera, and specialized instruments are used to remove the herniated portion of the disc. What distinguishes this intervention: * Small incisions (typically <1 cm) result in less soft tissue damage compared to traditional open surgery. * Real-time endoscopic visualization allows for precise disc removal and reduced trauma to surrounding structures such as muscles and ligaments. * Minimized postoperative pain and faster recovery times due to the less invasive nature of the procedure. * Outpatient or short hospital stay is often possible, contributing to faster patient discharge.
PROCEDUREMicrodiscectomy
Microdiscectomy is a conventional surgical technique for treating lumbar disc herniation, involving a small open incision. In this procedure, the surgeon makes an incision typically between 2-3 cm in length, then uses an operating microscope to gain magnified visualization of the herniated disc. The surgeon removes part of the lamina (laminotomy) to access the disc and nerves. Special instruments are used to remove the herniated portion of the disc that is compressing the spinal nerves, relieving symptoms such as pain, numbness, and weakness. What distinguishes this intervention: * Larger incision (2-3 cm) compared to FELD, but still smaller than traditional open discectomy, allowing better visualization. * Microscopic magnification allows precise removal of disc material while minimizing trauma to surrounding neural structures. * Direct access to the affected area via the removal of part of the lamina (laminotomy), offering a well-established and highly effective approach to reli
Sponsors
University of Opole
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18-85 years with symptoms of sciatica lasting more than 6 weeks * Shorter duration in cases where symptoms significantly impair normal functioning or in cases of muscle strength deficits * Symptoms correlate with MRI findings of lumbar spine pathology, showing the presence of intervertebral disc herniation (protrusion, extrusion, or sequestration) causing nerve root compression in the lumbar spine.
Exclusion criteria
* Previous lumbar spine surgery in the lumbar-sacral region * MRI findings showing degenerative or stenotic spinal canal changes * Multi-level pathology where identification of the pain source is not possible * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Back and Leg Pain Intensity (measured by the Visual Analog Scale [VAS]) | Baseline, 1 month, 3 months, 6 months, 12 months post-surgery | Description: The primary outcome measure will assess changes in back and leg pain intensity reported by patients using the Visual Analog Scale (VAS) at each follow-up. The reduction in pain scores will be compared between the FELD and MD groups to evaluate which technique provides superior pain relief over time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Disability (measured by the Oswestry Disability Index [ODI]) | Baseline, 1 month, 3 months, 6 months, 12 months post-surgery | This measure will assess the improvement in functional disability using the ODI, comparing the degree of disability reduction between the FELD and MD groups at each follow-up point. |
| Change in Overall Patient Well-Being (measured by the Core Outcome Measures Index [COMI]) | Baseline, 1 month, 3 months, 6 months, 12 months post-surgery | The COMI questionnaire will be used to evaluate changes in the patient's overall perception of their condition, including pain, function, and quality of life. Comparisons will be made between FELD and MD groups to assess which method leads to a greater improvement in patient well-being. |
| Recurrence Rate of Disc Herniation (measured by MRI and clinical assessment) | 1 month, 3 months, 6 months, 12 months post-surgery | The rate of recurrent disc herniation will be monitored through MRI scans and clinical evaluations. The rate of recurrence in both the FELD and MD groups will be compared to determine if one technique results in a higher recurrence rate. |
| Time to Return to Work | Up to 12 months post-surgery | This measure will assess the number of days taken for patients to return to their regular work activities post-surgery, comparing the recovery times between the FELD and MD groups. |
Countries
Poland
Outcome results
None listed