Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT07418944

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

Led by Helsinki University Central Hospital · Updated on 2026-05-14

122

Participants Needed

1

Research Sites

249 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-60 years
  • Diagnosed unilateral sciatica due to lumbar disc herniation confirmed by MRI at L3/4, L4/5, or L5/S1
  • Symptoms lasting at least 6 weeks
  • Worst leg pain score of 5 or higher on a numerical rating scale
  • Has not improved after at least one form of non-surgical care
  • Willing to have surgery and comply with study procedures
  • Able to give informed consent and communicate in the study language
Not Eligible

You will not qualify if you...

  • Uncertain nerve root compression
  • Spinal stenosis or other spinal conditions that may confuse results
  • Far lateral disc herniation
  • Serious neurological problems
  • Previous spinal surgery
  • Any reason preventing MRI scan
  • Body mass index over 35 or lumbar subcutaneous fat thicker than 50 mm by MRI
  • American Society of Anesthesiologists (ASA) classification greater than 2
  • Being pregnant

AI-Screening

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Trial Site Locations

Total: 1 location

1

Helsinki University Central Hospital

Helsinki, Finland

Actively Recruiting

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Research Team

O

Olli Rytsölä, MD

CONTACT

S

Study coordinator

CONTACT

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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