Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000826448
Ethics application status
Approved
Date submitted
5/07/2025
Date registered
1/08/2025
Date last updated
1/08/2025
Date data sharing statement initially provided
1/08/2025
Date results provided
1/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Image Guided Bilateral Transpedicular Basivertebral Nerve Ablation in Vertebrogenic Pain: Early Experience in Expanded Indications
Scientific title
A Prospective Evaluation of Image-Guided Bilateral Transpedicular Basivertebral Nerve Ablation for Vertebrogenic Low Back Pain: Early Outcomes in an Expanded Indication Cohort
Secondary ID [1] 314827 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vertebrogenic pain 338089 0
Pathologic spinal fracture 338090 0
inflammatory endplate osteitis associated with spondyloarthropathy 338091 0
hemangioma 338092 0
Condition category
Condition code
Musculoskeletal 334392 334392 0 0
Other muscular and skeletal disorders
Blood 334476 334476 0 0
Other blood disorders
Inflammatory and Immune System 334477 334477 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Theatre or CT suite based image guided bilateral transpedicular basivertebral nerve ablation. These are the same procedures performed in different settings. These are performed once, with a total procedure duration of 60-90mins. The dosage is listed below.

Theatre:
The procedures were performed by a spinal surgeon trained in the basivertebral nerve ablation technique with the patient prone under conscious sedation. Under fluoroscopic guidance, an 11- or 13-gauge introducer was advanced to a position near the juncture of the dorsal and medial one third of the vertebral body as viewed from lateral with fluoroscopic imaging. After insertion of the introducer and confirmation of depth on lateral, the fluoroscopy beam was then returned to the initial posterior oblique angle to visualise down the introducer. Once positioned, the introducer was removed and pediculotomy visualised. The Nimbus® (radiofrequency needle) was advanced into the pediculotomy to the vertebral body. Once both cannulas were inserted, lateral imaging was used to adjust depth of both cannulas to the juncture of the dorsal and medial one third of the vertebra. Contrast should be injected to exclude medial pedicle breach during placement. The commercially available 17-gauge Nimbus® radiofrequency (RF) needle was positioned to bracket the described nexus of the basivertebral nerve (BVN) as described by Antonacci and Bailey.
While optimal interelectrode distance is less than 20 mm, larger distances are feasible for lesioning due to the high electrical and thermal conductance of intravertebral trabecular bone marrow. Thermal concordance was readily established between the two cannulas with the cathode set to 80°C as observed by temperatures at the anode which will exceed 65°C. With technically correct performance, post-procedure MRI demonstrates two discrete foci of intense intravertebral ablation with clear changes to the trabecular bone 'stippling' (T2) between the cannulas.

CT suite:
The procedures were performed by a musculoskeletal interventional radiologist with over 15 years of image guided radio frequency ablation experience. Patients were placed prone on the CT gantry and limited scout scan and low dose helical scan of the treatment level performed to assess gantry tilt requirements. With the patient fasted, conscious intravenous sedation was administered. Using gantry tilt of 15-30 degrees depending on the level treated, transpedicular access with 11-to-13-gauge Jamshidi needles was achieved under CT fluoroscopy guidance. To optimise lesioning, a commercially available 17-gauge Nimbus 150mm multitined expandable electrode (MEE) RF cannula was positioned aiming for the probe tips to be at the junction of the middle and posterior one third of the vertebral body in the sagittal plane. Bipolar thermal radiofrequency ablation was performed between 85 to 90°C for six to eight minutes. Reproduction of usual vertebrogenic pain during the procedure was confirmed with patient questioning.
Intervention code [1] 331431 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342071 0
Satisfaction
Timepoint [1] 342071 0
2 month review post ablation
Secondary outcome [1] 449470 0
Pain
Timepoint [1] 449470 0
Baseline and 2 months post ablation

Eligibility
Key inclusion criteria
Chronic midline axial low back pain:
• Sharp in nature
• Aggravated by activity and flexion
• Not worsened by extension
• Non-neuropathic
• Imaging criteria (either of the following must be met):
• Presence of Modic Type 1 or Type 2 endplate changes on MRI
• If Modic changes absent: increased endplate uptake on Technetium-99m bone scan and/or SPECT-CT
• Criteria are based on published descriptions by Fischgrund and the Intracept™ protocol
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
• Significant spinal instability, including:
• Unstable fractures
• Spondylolisthesis greater than Grade II

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analysis performed by a student using Jamovi™ v. 2.3.21.0. Anonymised data was entered into Jamovi for analysis. Descriptive statistics produced and Student’s t-test conducted to compare Likert outcome scores between genders and indications. Calculation of sample size was not conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/10/2023
Date of last participant enrolment
Anticipated
Actual
31/01/2025
Date of last data collection
Anticipated
Actual
1/05/2025
Sample size
Target
30
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 319387 0
Self funded/Unfunded
Name [1] 319387 0
Resources, patients and staff time provided by senior author Dr Mario Zotti.
Country [1] 319387 0
Australia
Primary sponsor type
Individual
Name
Dr Mario Zotti - Back/Neck Clinic
Address
Country
Australia
Secondary sponsor category [1] 321873 0
Individual
Name [1] 321873 0
William Peters - Bond University
Address [1] 321873 0
Country [1] 321873 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317961 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 317961 0
Ethics committee country [1] 317961 0
Australia
Date submitted for ethics approval [1] 317961 0
01/08/2023
Approval date [1] 317961 0
02/10/2023
Ethics approval number [1] 317961 0
MZ00044

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142698 0
A/Prof Mario Zotti
Address 142698 0
Back/Neck Clinic, Tower 1 Level 4 1402/56 Scarborough St, Southport, QLD 4215
Country 142698 0
Australia
Phone 142698 0
+614 0084 5563
Fax 142698 0
Email 142698 0
[email protected]
Contact person for public queries
Name 142699 0
Mario Zotti
Address 142699 0
Back/Neck Clinic, Tower 1 Level 4 1402/56 Scarborough St, Southport, QLD 4215
Country 142699 0
Australia
Phone 142699 0
+614 0084 5563
Fax 142699 0
Email 142699 0
[email protected]
Contact person for scientific queries
Name 142700 0
Mario Zotti
Address 142700 0
Back/Neck Clinic, Tower 1 Level 4 1402/56 Scarborough St, Southport, QLD 4215
Country 142700 0
Australia
Phone 142700 0
+614 0084 5563
Fax 142700 0
Email 142700 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleNo BVNA Results.docx

Documents added automatically
No additional documents have been identified.