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RECRUITING
NCT07418944
NA

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

Sponsor: Helsinki University Central Hospital

View on ClinicalTrials.gov

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.

Official title: FINDISC-Pain, Finnish Discectomy Trial - a Randomised, Placebo-surgery Controlled Trial. An Efficacy Trial Designed to Prove That Discectomy Can Work.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

122

Start Date

2026-02-16

Completion Date

2030-12

Last Updated

2026-02-18

Healthy Volunteers

No

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

Locations (1)

Helsinki University Central Hospital

Helsinki, Finland