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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Repeat percutaneous facet joint denervation for chronic back pain: a prospective study for improvement in low back outcome score.
Scientific title
Repeat percutaneous facet joint denervation for chronic back pain: a prospective study for improvement in low back outcome score.
Universal Trial Number (UTN)
Trial acronym
Repeat RFJD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 2863 0
Condition category
Condition code
Musculoskeletal 2997 2997 0 0
Other muscular and skeletal disorders

Study type
Description of intervention(s) / exposure
Repeat Percutaneous radiofrequency facet joint denervation (neurotomy) - This involves lesioning via use of percutaneous electrodes of selected pain-producing lumbar medial branches percutaneously using radiofrequency with pulsed time cycle of 2×2 msec/second and maximum probe tip temperature of 90 degrees celsius. In this trial a single group will recieve a procedure and then a 12 month followup
Intervention code [1] 2593 0
Treatment: Other
Comparator / control treatment
Same group (i.e. subjects acting as their own control via their preoperative LBOS) but using baseline low back outcome scores before repeat radiofrequency facet joint denervation. The technique used for previous RFJD procedures done on this group used an identical radiofrequency technique and radiofrequency settings that will be done prospectively upon the same group (i.e. the same procedure is being repeated in the same group.
Control group

Primary outcome [1] 3879 0
Low back outcome score (Validated pain score: Greenough CG Fraser RD. Assessment of outcome in patients with low-back pain. Spine. 1992;17:36-41 )
Timepoint [1] 3879 0
12 months
Secondary outcome [1] 6523 0
Patient satisfaction as measured by survey
Timepoint [1] 6523 0
12 months

Key inclusion criteria
Previous success with facet joint denervation
Minimum age
18 Years
Maximum age
90 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Unsuccessful primary procedure
Unwillingness to participate

Study design
Purpose of the study
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
Single group
Other design features
Prospective Cohort study following subjects before and after a repeat facet joint denervation for chronic low back pain; The subjects will be consented to participate before recieving the treatment which they will recieve irrespective of their participation in the study or not (all participants will recieve the same intervention)
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 588 0

Funding & Sponsors
Funding source category [1] 3116 0
Self funded/Unfunded
Name [1] 3116 0
Mario Zotti
Address [1] 3116 0
51 Thomas St Unley South Australia (SA) 5061
Country [1] 3116 0
Primary sponsor type
Mario Zotti
51 Thomas St Unley South Australia (SA) 5061
Secondary sponsor category [1] 2804 0
Name [1] 2804 0
Orso Osti
Address [1] 2804 0
12 Walter St North Adelaide South Australia (SA) 5006
Country [1] 2804 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5093 0
Ethics committee address [1] 5093 0
Ethics committee country [1] 5093 0
Date submitted for ethics approval [1] 5093 0
Approval date [1] 5093 0
Ethics approval number [1] 5093 0

Brief summary
'Repeat percutaneous facet joint denervation for chronic back pain: a prospective study for improvement in low back outcome score - this study will involve between 65-75 participants who have had an initially successful facet joint denervation and will follow them prospectively as to the success, as judged by the LBOS, with their repeat procedure.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 28396 0
Address 28396 0
Country 28396 0
Phone 28396 0
Fax 28396 0
Email 28396 0
Contact person for public queries
Name 11553 0
Mario Zotti
Address 11553 0
51 Thomas St Unley South Australia (SA) 5061
Country 11553 0
Phone 11553 0
Fax 11553 0
Email 11553 0
Contact person for scientific queries
Name 2481 0
Mario Zotti
Address 2481 0
51 Thomas St Unley South Australia (SA) 5061
Country 2481 0
Phone 2481 0
Fax 2481 0
Email 2481 0

No information has been provided regarding IPD availability
Summary results
No Results