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

NCT07418944 | Recruiting DMC

• 1 other identifier: HUS/355/2025
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

randomized controlled trial; Placebos; Surgery; placebo-controlled trial; discectomy; patient acceptable symptoms state

Outcome Measures

Primary Outcomes (2)

• Worst leg pain intensity within past 24-hours (NRS 0-10, where 0 = no pain, 10 = worst possible pain)

  Worst leg pain intensity will be measured using a 11-point Numeric Rating Ccale (NRS 0-10, where 0 = no pain, 10 = worst pain imaginable)

  Recruitment, 1 day pre intervention, and 1 day, and 1, 3 and 6 weeks, and 3, 6 and 12 months post intervention. Primary endpoint at 6 weeks.

• Patient acceptable symptom state (PASS)

  PASS will be assessed by asking "Thinking about your recovery from back surgery - would you be satisfied with your current symptoms status (as experienced in the past 24-hours)?" Recorded as Yes / No. Further analysis will report the proportion of participants reporting a satisfactory symptom state at the primary endpoint (responder analysis).

  1, 3 and 6 weeks, and 3, 6 and 12 months post intervention. Primary endpoint at 6 weeks.

Secondary Outcomes (12)

• Oswestry Disability Index (ODI) (0-100, where 0 = no disability)

  Recruitment, 1 day pre intervention, and 6 weeks, and 3, 6 and 12 month post intervention

• Average leg pain intensity in past 24-hours, (NRS 0-10, where 0 = no pain, 10 = worst possible pain)

  Recruitment, 1 day pre intervention, and 1 day, 1, 3 and 6 weeks, 3, 6, and 12 months post intervention

• Back pain intensity in past 24-hours, (NRS 0-10, where 0 = no pain, 10 = worst possible pain)

  Recruitment, 1 day pre intervention, and 1 day, 1, 3 and 6 weeks, 3, 6, and 12 months post intervention

• Health-related quality of life (EuroQol 5-Dimension 5-Level (EQ-5D-5L) index value)

  Recruitment, 6 weeks and 12 months post intervention

• Health-related quality of life (EQ-5D Visual Analogue Scale (EQ VAS), range 0 to 100, where 100 = the best imaginable health state)

  Recruitment, 6 weeks and 12 months post intervention

Other Outcomes (2)

• Blinding fidelity (methodological measure)

  6 weeks post intervention

• Magnetic resonance imaging (MRI)

  Recruitment, 3 and 12 months

Study Arms (2)

Microdiscectomy

EXPERIMENTAL

Lumbar microdiscectomy

Procedure: Microdiscectomy

Placebo

PLACEBO COMPARATOR

Placebo-surgery

Procedure: Placebo-surgery

Interventions

Microdiscectomy PROCEDURE

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.

Microdiscectomy

Placebo-surgery PROCEDURE

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• NRS worst leg pain 5 or higher
• Patient has not responded to at least one form of non-operative care
• Patient willing to undergo surgery
• Patient willing and able to give consent and comply with study procedures
• Sufficient proficiency in the language of the study site to provide informed consent and comply with study procedures

You may not qualify if:

• Doubtful nerve root compression
• Spinal stenosis or any other confounding spinal condition
• Far lateral disc herniation
• Serious neurological deficit
• Previous spinal surgery
• Any contraindication to MRI
• BMI \> 35 or lumbar subcutaneous fat \> 50 mm as determined from the MRI
• ASA classification \> 2
• Being pregnant

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Finland

RECRUITING

MeSH Terms

Conditions

Sciatica

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Teppo Järvinen, Professor

  Helsinki University Central Hospital

  STUDY DIRECTOR

Central Study Contacts

Olli Rytsölä, MD

CONTACT

+358504270094; olli.rytsola@hus.fi

Study coordinator

CONTACT

saara.raatikainen@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All care providers except for the surgical team providing the study intervention will be masked (i.e. all postoperative care providers are masked). Study statistician will also be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant senior spine surgeon, MD

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 18, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After publication of main results, to be specified later.
• Access Criteria: To be determined.

Locations

FI (1)