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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHelsinki University Central Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Doubtful nerve root compression

Spinal stenosis or any other confounding spinal condition

Far lateral disc herniation

Serious neurological deficit

Trial design

Treatments tested in this trial

  • Microdiscectomy
  • Placebo-surgery

Treatment groups

122 Participants
are divided into 2 treatment groups