Actively Recruiting
Led by University of Aarhus · Updated on 2024-05-02
180
Participants Needed
1
Research Sites
52 weeks
Total Duration
U
University of Aarhus
Lead Sponsor
P
Private Hospital Moelholm
Collaborating Sponsor
Researchers are investigating whether selective spinal nerve root blocks (SNRB) can improve the diagnosis of radiculopathy caused by lumbar disc herniation, foraminal stenosis, and recess stenosis. The study aims to identify which patients might benefit from surgery by adding the results of a diagnostic SNRB to the surgical decision-making process. This is a prospective randomized controlled trial with patients who have suspected radiculopathy and radiological evidence of nerve root compression. Participants are randomized into two groups: one group receives the standard care plus a diagnostic SNRB, and the other group receives standard care alone. The SNRB procedure is guided by CT at Aarhus University or by fluoroscopy at a private hospital and uses drugs including omnipaque, betamethasone, and bupivacaine. The results of the SNRB are shared with the surgeon to aid in deciding whether surgery is necessary. Participants will be assessed at baseline and followed up at 1, 3, and 12 months after surgery or the decision not to operate. Assessments include the Oswestry Disability Index, EQ5D, SF-36, and pain ratings for leg and back pain. The main outcome measured is the minimum clinically important difference at 3 months. Secondary outcomes include changes in pain, quality of life, and disability scores. The study is sponsored by the University of Aarhus and plans to conclude by November 2027.
CONDITIONS
Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants randomized to the diagnostic group receive a selective nerve root block (SNRB) using CT or fluoroscopy guidance as part of the pre-operative workup before surgical decision-making.
1 visit (in-person)
Duration - Up to 1 month
Participants undergo standard care which may include surgery based on the surgical decision informed by diagnostic results or direct operation without SNRB.
Surgery and post-operative care visits as needed
Duration - 12 months
Participants are followed for recovery and assessment of pain and disability at 1, 3, and 12 months after surgery or decision not to operate.
3 visits (1 month, 3 months, and 12 months post-surgery or decision)
Total: 1 location
1
Aarhus University Hospital
Aarhus C, Denmark, 8000
Actively Recruiting
D
David Kocemba, MD
M
Mikkel Rasmussen, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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David Kocemba, Peter Andreas Andersen, Jakob Gram Carlsen...
https://pubmed.ncbi.nlm.nih.gov/41388268