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New treatment option for Lumbar Disc Herniation With Radiculopathy
Official title FINDISC-Pain, Finnish Discectomy Trial on the Benefits and Harms of Surgery in Patients With Lumbar Disc Herniation
ClinicalTrials.gov ID: NCT07418944
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join 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
You likely can't join 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Finland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.