Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
The overall purpose of the study is to investigate whether selective spinal nerve root blocks can improve diagnostics of radiculopathy due to lumbar disc herniation (LDH), foraminal stenosis (FS), and recess stenosis (RS), and hence identify the patients that will benefit from surgical intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years old
Suspected lumbar radiculopathy persistent ≥ 8 weeks
Radiological evidence of lumbar nerve root compression (herniated disc, recess stenosis, foraminal stenosis)
Disqualifiers
Prior lumbar spine surgery
Mental illness
Language barrier in Danish
Severe physical co-morbidity
Trial design
Design model
Parallel
Treatments tested in this trial
Selective nerve root block (SNRB)
Diagnostic testCT/Fluoroscopy guided nerve root block
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: BlockActive comparator 1 intervention
Group B: No-blockNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Minimum clinically important difference (MCID)
Difference in mean change on numerical rating scale for leg pain (NRS-LP) 3 months after surgery. The margin of non-inferiority will be set to = 1.6 points. Comparison will be made between patients in the SNRB group and patients in the control group surgery.
Time frame
3 months after surgery/decision not to operateSecondary outcomes
1
Leg pain
Difference in proportions reaching 1.6 points on NRS-LP 3 months after surgery/decision to not to operate. Comparison will be made between the SNRB group and the standard of care group.
Time frame
3 months after surgery/decision not to operate2
Back pain
Mean change in numerical rating scale for back pain (NRS-BP) 3 months after surgery/decision to not to operate. Comparison will be made between the SNRB group and the standard of care group.
Time frame
3 months after surgery/decision not to operate3
SF-36 (Short form 36)
SF-36 3 months after surgery/decision to not to operate. Comparison will be made between the SNRB group and the standard of care group.
Time frame
3 months after surgery/decision not to operate4
EQ5D (EuroQol 5D)
EQ5D 3 months after surgery/decision to not to operate. Comparison will be made between the SNRB group and the standard of care group.
Time frame
3 months after surgery/decision not to operateSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Private Hospital Moelholm
Collaborator
Source ClinicalTrials.gov