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NCT07895589
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Conditions: Lumbar Disc Herniation, Lumbar Radiculopathy, Lumbar Disc Herniation With Radiculopathy
Sex: All
Ages: 18 Years – 66 Years
Healthy volunteers: No
Phase: NA
Enrollment: 262
Sponsor: Karolinska Institutet
Location: Karolinska University Hospital Stockholm
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.
Eligibility Criteria
Inclusion Criteria:
* Participants must meet all of the following criteria:
Age ≥18 years and \
Source: ClinicalTrials.gov (NCT07895589). StuddyBuddy aggregates publicly available trial information.