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NOT YET RECRUITING
NCT07895589
NA

Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

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

PROCEDURE

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.

PROCEDURE

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