Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000108314
Ethics application status
Not yet submitted
Date submitted
22/02/2008
Date registered
27/02/2008
Date last updated
27/02/2008
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

Intervention/exposure
Study type
Interventional
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
Historical

Outcomes
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

Eligibility
Key inclusion criteria
Previous success with facet joint denervation
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unsuccessful primary procedure
Unwillingness to participate

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
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
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 588 0
5006

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

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
03/03/2008
Approval date [1] 5093 0
Ethics approval number [1] 5093 0

Summary
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

Contacts
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
Australia
Phone 11553 0
0400845563
Fax 11553 0
Email 11553 0
mariozotti@gmail.com
Contact person for scientific queries
Name 2481 0
Mario Zotti
Address 2481 0
51 Thomas St Unley South Australia (SA) 5061
Country 2481 0
Australia
Phone 2481 0
0400845563
Fax 2481 0
Email 2481 0
mariozotti@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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