Finnish comparison of microdiscectomy versus sham surgery for lumbar disc herniation
FINDISC-Pain, Finnish Discectomy Trial - a Randomised, Placebo-surgery Controlled Trial. An Efficacy Trial Designed to Prove That Discectomy Can Work.
This trial tests whether microdiscectomy provides better pain relief and recovery than a sham operation for adults with sciatica from a lumbar disc herniation who haven't improved after at least six weeks of non-surgical care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 1 site (Helsinki) |
| Trial ID | NCT07418944 on ClinicalTrials.gov |
What this trial studies
The FINDISC trial randomly assigns 122 adults with persistent sciatica from a single-level lumbar disc herniation to either conventional microdiscectomy or a placebo (sham) surgery in a 1:1 ratio. The sham procedure mimics anesthesia and the surgical approach but does not remove disc material, and patients and most healthcare staff are blinded to allocation while the surgical team is not. Outcomes include worst leg pain, functional recovery, quality of life, and harms, compared between groups to separate specific surgical effects from placebo responses. The trial is conducted at Helsinki University Central Hospital and targets participants who have not improved after at least six weeks of nonoperative care.
Who should consider this trial
Good fit: Adults 18–60 with unilateral radicular leg pain from a single-level lumbar disc herniation (L3/4, L4/5, or L5/S1), worst-leg pain NRS ≥5, symptoms for at least six weeks, and who have not improved with non-surgical care.
Not a fit: Patients with spinal stenosis, far-lateral herniation, previous spinal surgery, serious neurologic deficits, contraindications to MRI, BMI >35, ASA >2, pregnancy, or those who have already improved with conservative care are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the trial could show whether microdiscectomy offers real, specific pain relief and faster recovery beyond placebo for people with sciatica.
How similar studies have performed: Prior randomized trials have suggested surgery can give faster symptom relief than nonoperative care, but most were unblinded and the use of a placebo-controlled surgical design is novel for microdiscectomy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Helsinki
- Helsinki University Central Hospital — Helsinki, Finland (Recruiting)
Study contacts
- Study coordinator: Olli Rytsölä, MD
- Email: olli.rytsola@hus.fi
- Phone: +358504270094
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.