Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade

NCT ID: NCT06143813

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-09
• Study Completion Date: 2027-11-01

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)

Conditions

Radiculopathy Lumbar; Radiculopathy Sacral; Herniated Disc; Foraminal Stenosis; Stenosis, Spinal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Block

This group will receive standard of care + a selective nerve root block as part of the diagnostic work up.

Group Type: ACTIVE_COMPARATOR

Selective nerve root block (SNRB)

Intervention Type: DIAGNOSTIC_TEST

CT/Fluoroscopy guided nerve root block

No-block

This group will receive standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Selective nerve root block (SNRB)

CT/Fluoroscopy guided nerve root block

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Transforaminal nerve root block

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Private Hospital Moelholm

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Kocemba, MD

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Mikkel Rasmussen, MD

Role: STUDY_DIRECTOR

University of Aarhus

Bent Uhrbrand, MD

Role: STUDY_CHAIR

Private Hospital Moelholm

Locations

Aarhus University Hospital

Aarhus C, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

David Kocemba, MD

Role: CONTACT

davkoc@rm.dk

+45 23882198

Mikkel Rasmussen, MD

Role: CONTACT

mikkrasm@rm.dk

Facility Contacts

David Kocemba, MD

Role: primary

davkoc@rm.dk

Mikkel Rasmussen, MD

Role: backup

mikkrasm@rm.dk

Other Identifiers

PLAN

Identifier Type: -

Identifier Source: org_study_id