Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade

Study Overview
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Brief Summary
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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.

Detailed Description
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The study is designed as a prospective randomized controlled trial, using a two-group stratified block-randomization, evaluating the effect of adding the outcome of a diagnostic SNRB to surgical decision-making. Stratification will be based on the study site. Block size will be 4, 6, or 8 and in random order. All patients referred to our departments with suspected radiculopathy and radiological evidence of root compression are eligible for inclusion. Patients will be randomized to either standard care or SNRB after the consultation. Results of the SNRB will be available to the surgeon before deciding finally whether to operate or not. Hence, the intervention adds the outcome of the diagnostic SNRB to the shared surgical decision-making. Study outline: Baseline: Demographics, Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded 1-month follow-up after surgery: Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded 3-months follow-up after surgery: Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded 12-months follow-up after surgery: Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded Randomization: Using RedCap patients will be randomized to receive a SNRB as part of the pre-operative workup or to direct operation. SNRB-procedure: At Aarhus University, the SNRB will be performed using CT-guidance; at Private Hospital Moelholm, the SNRB procedure will be guided by fluoroscopy. Drugs used are omnipaque (0,2 ml), betamethasone (0,5 ml) and bupivacain (0,5 ml)

Official Title
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Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade

Conditions
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Radiculopathy Lumbar, Radiculopathy Sacral, Herniated Disc, Foraminal Stenosis, Stenosis, Spinal

Intervention / Treatment
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* Diagnostic Test: Selective nerve root block (SNRB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years old Suspected lumbar radiculopathy persistent ≥ 8 weeks Radiological evidence of lumbar nerve root compression (herniated disc, recess stenosis, foraminal stenosis) Exclusion Criteria: Prior lumbar spine surgery Mental illness Language barrier in Danish Severe physical co-morbidity Known allergies to medicine used in the study Pregnant Plans to move abroad during the next 12-months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Block<br>This group will receive standard of care + a selective nerve root block as part of the diagnostic work up. | Diagnostic Test: Selective nerve root block (SNRB)<br>* CT/Fluoroscopy guided nerve root block<br>* Other names: Transforaminal nerve root block;|
| No Intervention: No-block<br>This group will receive standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum clinically important difference (MCID) | Fraction of patients not reaching minimum clinically important difference (MCID) on the numerical rating scale for leg pain (NRS-LP) one year following surgery. | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg pain, numerical rating scale-leg pain (NRS-LP) | Mean change in NRS-LP score from baseline to one year after surgery | 1 year after surgery | 
| Back pain, numerical rating scale-back pain (NRS-BP) | Mean change in NRS-BP score from baseline to one year after surgery | 1 year after surgery | 
| Patient health: Short-Form 36 (SF-36) | Mean change in SF-36 score from baseline to one year after surgery | 1 year after surgery | 
| Quality of life: EQ-5D | Mean change in EQ5D score from baseline to one year after surgery | 1 year after surgery | 
| Disability: Oswestry Disability Index (ODI) | Mean change in ODI score from baseline to one year after surgery | 1 year after surgery |