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

NCT07418944 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Lumbar Disc Herniation With Radiculopathy
  • Sciatica

Interventions

PROCEDURE

Microdiscectomy

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.

PROCEDURE

Placebo-surgery

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

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Teppo Järvinen, Professor · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-19
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07418944 on ClinicalTrials.gov