NCT06143813

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Nov 2023Nov 2027

First Submitted

Initial submission to the registry

November 9, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

May 2, 2024

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

November 9, 2023

Last Update Submit

April 29, 2024

Conditions

Radiculopathy LumbarRadiculopathy SacralHerniated DiscForaminal StenosisStenosis, Spinal

Outcome Measures

Primary Outcomes (1)

  • Minimum clinically important difference (MCID)

    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.

    3 months after surgery/decision not to operate

Secondary Outcomes (6)

  • 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

  • EQ5D (EuroQol 5D)

    3 months after surgery/decision not to operate

  • ODI

    3 months after surgery/decision not to operate

  • +1 more secondary outcomes

Study Arms (2)

Block

ACTIVE COMPARATOR

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)

No-block

NO INTERVENTION

This group will receive standard of care.

Interventions

Selective nerve root block (SNRB)DIAGNOSTIC_TEST

CT/Fluoroscopy guided nerve root block

Also known as: Transforaminal nerve root block
Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years old
  • Suspected lumbar radiculopathy persistent ≥ 8 weeks
  • Radiological evidence of lumbar nerve root compression (herniated disc, recess stenosis, foraminal stenosis)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus C, 8000, Denmark

RECRUITING

Related Publications (1)

  • 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. doi: 10.1186/s12891-025-09395-0. Online ahead of print.

    PMID: 41388268DERIVED

MeSH Terms

Conditions

Intervertebral Disc DisplacementSpinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • David Kocemba, MD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

  • Mikkel Rasmussen, MD

    University of Aarhus

    STUDY DIRECTOR

  • Bent Uhrbrand, MD

    Private Hospital Moelholm

    STUDY CHAIR

Central Study Contacts

David Kocemba, MD

CONTACT

+45 23882198davkoc@rm.dk

Mikkel Rasmussen, MD

CONTACT

mikkrasm@rm.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 22, 2023

Study Start

November 9, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

May 2, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)