Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade (PLAN)

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.

Study Overview

• Status: Recruiting
• Conditions: Herniated Disc; Radiculopathy Lumbar; Stenosis, Spinal; Foraminal Stenosis; Radiculopathy Sacral
• Intervention / Treatment: Diagnostic test: Selective nerve root block (SNRB)

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)

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Kocemba, MD; Phone Number: +45 23882198; Email: davkoc@rm.dk
• Study Contact Backup: Name: Mikkel Rasmussen, MD; Email: mikkrasm@rm.dk

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Recruiting
    • Aarhus University Hospital
    • Contact: Mikkel Rasmussen, MD; Email: mikkrasm@rm.dk
    • Contact: David Kocemba, MD; Email: davkoc@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Block; 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); CT/Fluoroscopy guided nerve root block; Other Names: Transforaminal nerve root block
No Intervention: No-block; This group will receive standard of care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Private Hospital Moelholm
• Investigators: Principal Investigator: David Kocemba, MD, University of Aarhus; Study Director: Mikkel Rasmussen, MD, University of Aarhus; Study Chair: Bent Uhrbrand, MD, Private Hospital Moelholm

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Radiculopathy; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: PLAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes