Actively Recruiting
FINDISC-Pain, Finnish Discectomy Trial - a Randomised, Placebo-surgery Controlled Trial Evaluating Microdiscectomy for Lumbar Disc Herniation with Sciatica
Led by Helsinki University Central Hospital · Updated on 2026-05-22
122
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying whether microdiscectomy, a common back surgery, is effective and safe for treating sciatica caused by a lumbar disc herniation. The trial focuses on adults aged 18 to 60 whose leg pain has not improved after at least six weeks of non-surgical treatment. It aims to provide clear evidence comparing real surgery to placebo surgery to help patients and doctors make informed decisions. Participants are randomly assigned to receive either the actual microdiscectomy surgery, which involves removing herniated disc material through a surgical approach, or a placebo surgery that mimics the procedure without removing any disc material or bone. Only the surgical team knows which procedure was performed; patients and most healthcare staff do not. Both groups receive standard post-operative care at specialized spine centers. Throughout the study, participants will be monitored for pain levels, symptom improvement, disability, quality of life, and any adverse events. Assessments occur before surgery and at several points up to one year after the procedure. An independent board oversees safety, and data are securely collected by blinded staff. The study includes thorough follow-up to compare outcomes between real and placebo surgery over time.
CONDITIONS
Brief Title
FINDISC-Pain, Finnish Discectomy Trial on the Benefits and Harms of Surgery in Patients With Lumbar Disc Herniation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-60 years
- Diagnosed unilateral lower extremity radiculopathy (sciatica) caused by lumbar disc herniation
- Single lumbar disc herniation at L3/4, L4/5, or L5/S1 confirmed by MRI
- Symptoms lasting at least 6 weeks
- Worst leg pain rated 5 or higher on a numeric scale
- No improvement after at least one type of non-surgical treatment
- Willing to undergo surgery
- Able and willing to give informed consent and follow study procedures
- Proficient in the study site's language to understand consent and procedures
You will not qualify if you...
- Unclear nerve root compression
- Spinal stenosis or other spinal conditions that could interfere
- Far lateral disc herniation
- Serious neurological deficits
- Previous spinal surgery
- Contraindication to MRI
- Body mass index over 35 or lumbar subcutaneous fat over 50 mm on MRI
- ASA physical status classification higher than 2
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo either microdiscectomy or placebo surgery, followed by standard post-operative care at the hospital.
1 surgical procedure visit
Duration - 12 months
Participants are monitored for recovery, pain, function, and any adverse events after surgery.
Visits on Day 1, Weeks 1, 3, 6, and Months 3, 6, and 12 post intervention
Trial Site Locations
Total: 1 location
1
Helsinki University Central Hospital
Helsinki, Finland
Actively Recruiting
Research Team
O
Olli Rytsölä, MD
S
Study coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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