FINDISC-Pain

Why is this trial needed?

Sciatica, most commonly caused by lumbar disc herniation (LDH), is among the most disabling pain conditions, with a lifetime incidence up to 40%. Although microdiscectomy is considered the “gold standard” surgical treatment for LDH, prior studies comparing it to non-operative care have limitations, including high crossover rates and short-term follow-up. Recent high-quality evidence has suggested modest short-term benefits of surgery over non-operative care, but these trials could not fully separate the specific treatment effect from placebo effects inherent to surgical interventions.

Given the widespread use of microdiscectomy and substantial global variation in practice, there is a critical need for a placebo-controlled trial to rigorously evaluate its true efficacy.

What is the primary objective of the FINDISC-PAIN trial?
To determine whether microdiscectomy is more effective than placebo surgery in relieving leg pain in patients with persistent sciatica due to LDH.

What is the study design?

FINDISC-PAIN is a multicenter, prospective, randomized, placebo-controlled trial. The placebo procedure will mimic microdiscectomy but omit the removal of herniated disc material or decompression of the nerve root. The primary outcome is resolution of leg pain at 6 weeks post-surgery, complemented by responder analyses and longer-term follow-up.

Where are we now?

This is our group’s 5th/6th placebo-controlled surgical trial, building on the experience from the previous completed (FIDELITY, FIMPACT, and FIRST) and ongoing (FINTASY, ARC: more information to come soon!).

The FINDISC-PAIN protocol has been approved by the Helsinki University Hospital IRB, and patient recruitment is expected to begin later this year. A new chapter in placebo-controlled spine surgery research is about to unfold—more updates will follow soon!

Project team

Olli Rytsölä – Pirjo Toivonen – Teija Lund – Tomasz Czuba

Contributors

Katri Pernaa - Ville Leinonen - Jyrki Kankare - Tom Asklöf – Martin Lehecka – Jari Siironen - Pietari Kinnunen - Jarkko Halme - Petri Voutilainen - Janek Frantzén - Jyrki Salmenkivi - Liisa Pekkanen - Kati Kyrölä