FINDISC-Pain, Finnish Discectomy Trial on the Benefits and Harms of Surgery in Patients With Lumbar Disc Herniation
FINDISC-Pain, Finnish Discectomy Trial - a Randomised, Placebo-surgery Controlled Trial. An Efficacy Trial Designed to Prove That Discectomy Can Work.
Helsinki University Central Hospital
122 participants
Feb 16, 2026
INTERVENTIONAL
Conditions
Summary
The FINDISC trial studies whether common back operation, microdiscectomy, is effective and safe for treating sciatica caused by a lumbar disc herniation. The study includes people whose leg pain has not improved after at least six weeks of non-surgical treatment. The FINDISC trial aims to recruit and randomly allocate 122 participants to receive either the actual operation (discectomy) or a placebo (sham) surgery. The placebo (sham) procedure involves anesthesia and an approach similar to the real operation, but no removal of disc material or bone. Participants and healthcare staff, excluding the surgical team, will not know which treatment was given. The study compares pain relief, recovery, daily functioning, quality of life, and harms between the two groups. The goal of the study is to provide reliable evidence to help patients and clinicians decide whether microdiscectomy offers meaningful benefits compared with placebo surgery.
Eligibility
Inclusion Criteria9
- Age 18-60 years
- Diagnosed unilateral lower extremity radiculopathy (sciatica) secondary to lumbar disc herniation (LDH)
- Single LDH at the level of L3/4, L4/5 or L5/S1 on magnetic resonance imaging
- Symptom duration minimum 6 weeks
- NRS worst leg pain 5 or higher
- Patient has not responded to at least one form of non-operative care
- Patient willing to undergo surgery
- Patient willing and able to give consent and comply with study procedures
- Sufficient proficiency in the language of the study site to provide informed consent and comply with study procedures
Exclusion Criteria9
- Doubtful nerve root compression
- Spinal stenosis or any other confounding spinal condition
- Far lateral disc herniation
- Serious neurological deficit
- Previous spinal surgery
- Any contraindication to MRI
- BMI \> 35 or lumbar subcutaneous fat \> 50 mm as determined from the MRI
- ASA classification \> 2
- Being pregnant
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Interventions
Lumbar microdiscectomy involves a surgical approach with skin and adipose layer incision, and subperiosteal dissection of posterior spinal muscles. After the approach the intervention involves lumbar spinal canal entry, resection of ligamentum flavum and removal of herniated disc fragments. Removal of bone from lamina and intervertebral disc space entry are performed only when necessary.
The placebo-surgery procedure involves an identical incision and approach as in the microdiscectomy group, but it does not include entry to the spinal canal, and no removal of disc material or bone
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07418944