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Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Sponsor: Karolinska Institutet
Summary
The SELDISC trial will investigate whether a selective nerve root block can reduce the need for surgery in adults with a herniated disc in the lower back. A herniated disc can irritate a nerve and cause pain that travels down the leg. A nerve root block delivers a local anaesthetic and a corticosteroid near the affected nerve to relieve pain and inflammation. The study will include 262 adults aged 18-66 years who have persistent leg symptoms despite non-surgical treatment and have been assessed by a spine surgeon as eligible for surgery. Participants will be randomly assigned to receive either a selective nerve root block or a sham procedure that mimics the treatment without delivering the active medication near the nerve. Each participant will have an equal chance of receiving either procedure. Participants and the study staff assessing their outcomes will not know which procedure was given. The radiologist performing the procedure will know the allocation. The main question is whether fewer participants in the nerve root block group undergo surgery within 12 months after randomisation. The study will also compare pain, disability, quality of life, time to surgery, medication use, sick leave, healthcare use and adverse events between the groups.
Official title: SELDISC - A Trial on SELective Nerve Root Block for Lumbar DISC Herniation
Key Details
Gender
All
Age Range
18 Years - 66 Years
Study Type
INTERVENTIONAL
Enrollment
262
Start Date
2027-01
Completion Date
2036-12-31
Last Updated
2026-10-27
Healthy Volunteers
No
Interventions
Selective Nerve Root Block
Fluoroscopy-guided needle placement at the affected lumbar nerve root, followed by contrast administration to confirm needle position and injection of a local anaesthetic and a depot corticosteroid.
Sham Procedure
Superficial local anaesthesia and fluoroscopy-guided needle placement to mimic a selective nerve root block, without contrast or therapeutic injectate administration near the nerve root.
Locations (2)
Karolinska University Hospital
Stockholm, Sweden
Stockholm Center for Spine Surgery (RKC)
Stockholm, Sweden