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FINDISC-Pain, Finnish Discectomy Trial on the Benefits and Harms of Surgery in Patients With Lumbar Disc Herniation

RecruitingNAAges 18 Years - 60 YearsAllHelsinki University Central Hospital
NCT07418944 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 me

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • Microdiscectomy
  • Placebo-surgery
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Where

1 site
Helsinki University Central Hospital
Helsinki, Finland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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