Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Selective nerve root block (SNRB).
- Who it may be relevant to
- Registry conditions: Radiculopathy Lumbar, Radiculopathy Sacral, Herniated Disc, Foraminal Stenosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 test Selective nerve root block (SNRB)
CT/Fluoroscopy guided nerve root block
Primary outcome measures
- Minimum clinically important difference (MCID) [Time frame: 3 months after surgery/decision not to operate]
Secondary outcome measures (6)
- Leg pain [Time frame: 3 months after surgery/decision not to operate]
- Back pain [Time frame: 3 months after surgery/decision not to operate]
- SF-36 (Short form 36) [Time frame: 3 months after surgery/decision not to operate]
- EQ5D (EuroQol 5D) [Time frame: 3 months after surgery/decision not to operate]
- ODI [Time frame: 3 months after surgery/decision not to operate]
- Subanalysis [Time frame: 3 months after surgery]
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
- Pregnant
- Plans to move abroad during the next 12-months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Denmark · 1 center
- Aarhus University Hospital — Aarhus C
Publications
- Kocemba D, Andersen PA, Carlsen JG, Schulz MK, Uhrbrand B, Dinesen H, Mikkelsen R, Thygesen M, Rasmussen MM. The PLAN trial: precision treatment of lumbar spine surgery with advanced nerve root blockade - protocol for a prospective, investigator-initiated, randomized non-inferiority trial. BMC Musculoskelet Disord. 2025 Dec 12;27(1):39. doi: 10.1186/s12891-025-09395-0. PMID 41388268
Identifiers
NCT: NCT06143813 · PLAN