Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Radiculopathy Lumbar
- Sponsor
- University of Aarhus
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Minimum clinically important difference (MCID)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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)
Investigators
Eligibility Criteria
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
- •Plans to move abroad during the next 12-months
Outcomes
Primary Outcomes
Minimum clinically important difference (MCID)
Time Frame: 3 months after surgery/decision not to operate
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.
Secondary Outcomes
- EQ5D (EuroQol 5D)(3 months after surgery/decision not to operate)
- Leg pain(3 months after surgery/decision not to operate)
- Back pain(3 months after surgery/decision not to operate)
- SF-36 (Short form 36)(3 months after surgery/decision not to operate)
- ODI(3 months after surgery/decision not to operate)
- Subanalysis(3 months after surgery)