Description

FINDISC is a randomized, placebo-surgery-controlled clinical trial evaluating the efficacy and safety of microdiscectomy for lumbar disc herniation causing sciatica. The trial includes adults with persistent sciatica symptoms that have not resolved despite at least six weeks of nonoperative care.

Sciatica caused by lumbar disc herniation is a common and disabling condition that can result in prolonged pain, functional limitations, and absence from work. Although most patients improve without surgery, microdiscectomy is frequently offered to patients with ongoing symptoms, and the use of this procedure varies substantially across countries and healthcare systems. Previous randomized trials suggest that surgery may provide faster symptom relief than nonoperative treatment; however, the magnitude and durability of this benefit remain uncertain. Most existing studies are unblinded and have high rates of crossover from nonoperative care to surgery, which limits the ability to determine the true treatment effect of the surgical procedure itself. Because surgical interventions are associated with placebo effects, particularly for subjective outcomes such as pain and perceived recovery, a placebo- surgery-controlled trial is needed to distinguish the specific effects of microdiscectomy from nonspecific effects related to undergoing surgery.

Participants are randomized in a 1:1 ratio to receive either conventional microdiscectomy or placebo surgery. The placebo procedure is designed to mimic surgery but does not include entry to the spinal canal, i.e. removal of disc material or bone. Participants, healthcare professionals involved in post-operative care, outcome assessors, data analysts, and investigators interpreting the results are blinded to treatment allocation. The surgical team performing the procedure is not blinded and has no role in further care and follow-up of the participants.

Outcomes assessed include pain, patient acceptable symptom state (PASS), global perceived recovery, disability, health-related quality of life, and the frequency of serious adverse events and reoperations. The study uses a superiority design, with the hypothesis that microdiscectomy leads to faster symptom relief than placebo surgery while maintaining an acceptable safety profile.

All procedures are performed at tertiary spine centers by experienced orthopedic or neurosurgeons. Post-operative care follows standard hospital practice, with general guidance provided to ensure consistency across sites.

Eligible patients who decline randomization are invited to participate in a parallel observational cohort, from which only baseline data are collected to assess potential selection bias.

A pilot phase enrolling 30 participants at one center is conducted to assess feasibility and safety. If no major protocol changes are required, data from the pilot phase will be included in the main trial analyses.

Participant safety is overseen by an independent Data Safety Monitoring Board (DSMB), which monitors adverse events and approves the statistical analysis plan. Trial data are collected by trained research staff blinded to treatment allocation and stored in a secure electronic data capture system.