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.
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
Doubtful nerve root compression
Spinal stenosis or any other confounding spinal condition
Far lateral disc herniation
Serious neurological deficit
Parallel
Microdiscectomy
Procedure/SurgeryLumbar 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.
Placebo-surgery
Procedure/SurgeryThe 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
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)
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).
Oswestry Disability Index (ODI) (0-100, where 0 = no disability)
Average leg pain intensity in past 24-hours, (NRS 0-10, where 0 = no pain, 10 = worst possible pain)
Back pain intensity in past 24-hours, (NRS 0-10, where 0 = no pain, 10 = worst possible pain)
Health-related quality of life (EuroQol 5-Dimension 5-Level (EQ-5D-5L) index value)
EQ-5D-5L questionnaire, Finnish language version, using the Swedish value set. Score ranges from values below 0 (health states considered worse than death) to 1.00 (full health), where higher scores indicate better health-related quality of life.
Blinding fidelity (methodological measure)
Participant assumed group (study arm) allocation as Microdiscectomy / Placebo / Uncertain
Magnetic resonance imaging (MRI)
Radiological assessment for lumbar disc herniation as Yes/No. If yes, further assessment of side (right / left), level (L3/4, L4/5, L5/S1) and type of hernia (protrusion / extrusion / sequestered). Also if yes, nerve root compression assessed on a 4-point scale: Certain / Probable (likelihood \> 50%) / Possible (likelihood \< 50%) / Definitely not
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