Foraminal Stenosis, Herniated Disc, Radiculopathy Lumbar, Radiculopathy Sacral, Stenosis, Spinal
Conditions
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)
Interventions
DIAGNOSTIC_TESTSelective nerve root block (SNRB)
CT/Fluoroscopy guided nerve root block
Sponsors
Private Hospital Moelholm
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimum clinically important difference (MCID) | 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
| Measure | Time frame | Description |
|---|---|---|
| Back pain | 3 months after surgery/decision not to operate | 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. |
| SF-36 (Short form 36) | 3 months after surgery/decision not to operate | 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. |
| Leg pain | 3 months after surgery/decision not to operate | 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. |
| ODI | 3 months after surgery/decision not to operate | Oswestry Disability Index (ODI) 3 months after surgery/decision to not to operate. Comparison will be made between the SNRB group and the standard of care group. |
| Subanalysis | 3 months after surgery | Fraction of patients not reaching minimum clinically important difference (MCID) on the numerical rating scale for leg pain (NRS-LP) 3 months after surgery (MCID NRS-LP = 1.6 points). Comparison will be made between patients in the SNRB group who underwent surgery and patients in the control group that underwent surgery. |
| EQ5D (EuroQol 5D) | 3 months after surgery/decision not to operate | EQ5D 3 months after surgery/decision to not to operate. Comparison will be made between the SNRB group and the standard of care group. |
Countries
Denmark
Contacts
Primary ContactDavid Kocemba, MD
Backup ContactMikkel Rasmussen, MD
Outcome results
None listed