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Trial registered on ANZCTR


Registration number
ACTRN12617000622303
Ethics application status
Approved
Date submitted
11/02/2017
Date registered
1/05/2017
Date last updated
1/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of Pain relief in Chronic Low Back Pain sufferers given radio frequency lesions to the medial branch nerves with patient selection based on local anaesthetic and placebo injections .
Scientific title
A prospective study of analgesia response to Radiofrequency ablation of lumbar zygo-apophyseal joints in Chronic low back pain with selection based on placebo controlled diagnostic medial branch blocks
Secondary ID [1] 290999 0
None
Universal Trial Number (UTN)
U1111-1191-9572
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain 301769 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301459 301459 0 0
Other physical medicine / rehabilitation
Musculoskeletal 301726 301726 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1: Medial Branch nerve block of lumbar zygoapophyseal joints with local anaesthetic
Dose 0.5ml of bupivacaine 0.5% at each nerve block up to a maximum of 6 blocks equals 3ml in total. The number and location of blocks is decided by clinical and radiological correlation of pain area and pathological joints. A maximum of 2 joints bilaterally in the lumbar spine are to be blocked or 3 adjacent levels unilaterally.
Duration : Single injection over 5 seconds
Mode : Injection with needle under image guidance in operating theatre
Description of intervention
Participants attend hospital for clinical assessment and attend on a separate occasion for intervention.
Patient information sheet and consent forms are provided to the participants
Participants initially receive medial branch blocks in the lumbar spine by a pain management specialist. This is performed in an operating theatre and their skin is painted with antiseptic (chlorhexidine 2%) The participants also receive a small dose of radio-opaque dye during the injection (Isovue 300 total 3mls)

If adequate pain relief is obtained ( 50% pain relief) they then proceed to Phase 2 after a minimum of 1 week.
Duration of time between Phase 1 and Phase 2 - 1-4 weeks

Phase 2
Radio frequency neurotomy of the lumbar zygoapophyseal joints.

Participants have a radio frequency lesion to the medial branch nerves supplying the zygo-apophyeseal joints that have previously been blocked in phase 1 in hospital by the same medical team.
Prior to this the participants discuss the procedure with the medical team.
Their baseline pain levels are assessed. The participants enter the operating theatre. An intravenous cannula is inserted. Sedation is administered intravenously with fentanyl up to 100 microgrammes and midazolam up to 5 milligrammes. Sterile technique is used and antiseptic (povidone Iodine) is applied to the skin. Local anaesthetic is administered ( lidocaine 1% up to 20mls ) with a small needle (25g) . Under image guidance with X ray a sterile procedure is performed with needles (20g and 10 m long) and a radio frequency generator to heat the nerves supplying sensation to the zygo-apophyseal joints that have been previously blocked in phase 1. (radio frequency neurotomy). Pain relief response to the radio frequency neurotomy is assessed by the research assistant and the nursing staff immediately post procedure and at regular time points after the procedure up to and including 3 months.
Intervention code [1] 296959 0
Treatment: Surgery
Intervention code [2] 296960 0
Diagnosis / Prognosis
Intervention code [3] 296961 0
Treatment: Drugs
Comparator / control treatment
In phase 1 , 80% participants receive a control injection with placebo (0.9% saline) and. 20 % receive a control injection of bupivacaine 0.5 % to control for expectation responses.
Phase 1: Control Arm - participants receive Medial Branch nerve block of lumbar zygoapophyseal joints with placebo or bupivacaine 0.5%
Dose 0.5ml of saline 0.9% or 0.5 ml of Bupivacaine 0.5% at each nerve block up to a maximum of 6 blocks equals 3ml in total.
This control arm may occur as the first or second injection and the subject will receive the active intervention at the other time point

Duration : Single injection over 5 seconds
Mode : Injection with needle under image guidance in operating theatre
Description of intervention :
Participants attend hospital for clinical assessment and attend on a separate occasion for intervention.
The duration between the injections is a minimum of 1 week and there is no maximum
Patient information sheet and consent forms are provided to the participants
Participants initially receive medial branch blocks in the lumbar spine by a pain management specialist. This is performed in an operating theatre and their skin is painted with antiseptic (chlorhexidine 2%) The participants also receive a small dose of radio-opaque dye during the injection (Isovue 300 total 3mls) If adequate pain relief is obtained ( 50% pain relief) they then proceed to Phase 2
Control group
Placebo

Outcomes
Primary outcome [1] 300855 0
% Pain relief (assessed by average pain on Numeric rating scale 0-10) from diagnostic medial branch block
Timepoint [1] 300855 0
Checked at baseline before administration of the block. Following the time of completion of the last medial branch block the outcome is assessed at 10 minutes (post injection completion ) and at 1 hour and 2 hours by a registered nurse and also hourly for a total of 6 hours post injection completion by self report.
Primary outcome is assessed at 1 hour and compared with baseline.
Primary outcome [2] 300856 0
Pain relief (assessed by average pain level on numeric rating scale 0-10 ) from radio frequency neurotomy
Timepoint [2] 300856 0
Checked at baseline and at 3 months post radio frequency neurotomy
Secondary outcome [1] 331044 0
Change in disability as measured on Roland and Morris disability questionnaire
Timepoint [1] 331044 0
Assessed at baseline and at 3 months post radio frequency neurotomy
Secondary outcome [2] 331045 0
Change in Depression and anxiety on DASS scale
Timepoint [2] 331045 0
Assessed at baseline and at 3 months post radio frequency neurotomy
Secondary outcome [3] 331047 0
Change in self efficacy measured by PSEQ
Timepoint [3] 331047 0
Assessed at baseline and at 3 months post radio frequency neurotomy
Secondary outcome [4] 331049 0
Change in catastrophic beliefs as measured by PRSS
Timepoint [4] 331049 0
Assessed at baseline and at 3 months post radio frequency neurotomy

Eligibility
Key inclusion criteria
Chronic Low Back Pain for greater than 6 months
aged 18 to 80
Clinical features of lumbar Z joint pain: pain on palpation over the joints (no more than two levels bilaterally or three levels unilaterally) or reproduction or increased lumbar spine pain with lumbar spine extension/lateral flexion/rotation.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
displays the presence of an active major mental disorder (e.g. psychosis, dementia, major depression with active suicidal ideation)
displays evidence of a primary drug addiction problem
pregnancy
prior low back surgery
prior treatment with radio frequency neurotomy
coagulation problems
infection
upper motor signs
unstable neurological deficit.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque envelopes with research assistant communicated to clinicians and not to assessing assistant or investigator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase 1 is diagnostic and participants receive 2 injections in a randomised and blinded fashion. The control injection may be active or placebo and so this is not a pure crossover design.

Phase 2 is an open label active intervention
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on previous publications we expected 30% significant placebo response and 40% to have significant response to local anaesthetic injection without significant placebo response.
The responses are divided into categorical responses for the primary outcome and analysed by repeated analysis of variance. Some further descriptive analysis is planned with simple frequency analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7384 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 15177 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 295424 0
Other Collaborative groups
Name [1] 295424 0
Australian and New Zealand College of Anaesthetists
Address [1] 295424 0
630 St Kilda Road
Melbourne
Victoria 3004
Country [1] 295424 0
Australia
Funding source category [2] 295600 0
Commercial sector/Industry
Name [2] 295600 0
St Jude Medical Australia Pty Ltd
Address [2] 295600 0
17 Sam Johnson Way, Lane Cove West NSW 2066
Country [2] 295600 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Pacific Highway
St Leonards
NSW 2065
Country
Australia
Secondary sponsor category [1] 294244 0
None
Name [1] 294244 0
Address [1] 294244 0
Country [1] 294244 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296757 0
The Northern Sydney Central Coast Area Health Human Research Ethics Committee
Ethics committee address [1] 296757 0
NSLHD Research Office
Level 13, Kolling Building
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 296757 0
Australia
Date submitted for ethics approval [1] 296757 0
06/12/2005
Approval date [1] 296757 0
22/12/2005
Ethics approval number [1] 296757 0
0512-225M(SP)

Summary
Brief summary
120 Patients referred with chronic low back pain clinically arising from the facet joints were referred and assessed for suitability for diagnostic medial branch blocks. The patients had 2 blocks performed with either bupivacaine then saline or vice versa or bupivacaine on both occasions in a double blind randomly controlled prospective fashion. Any patient with 50% relief to any block was offered a radio frequency neurotomy and their analgesia and function and distress was measured post procedure for 3 months.
Trial website
N/A
Trial related presentations / publications
1. PhD thesis Finniss D. Placebo effects in the diagnosis and managment of chronic low back pain: Sydney University ; 2012.
Public notes

Contacts
Principal investigator
Name 71966 0
Dr Damien Finniss
Address 71966 0
Dept of Anaesthesia
Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065
Country 71966 0
Australia
Phone 71966 0
+61299267111
Fax 71966 0
+61294631050
Email 71966 0
damien.finniss@sydney.edu.au
Contact person for public queries
Name 71967 0
A/Prof Charles Brooker
Address 71967 0
Michael J Cousins Pain Management and Research Centre
Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065
Country 71967 0
Australia
Phone 71967 0
+61294631500
Fax 71967 0
+61294631050
Email 71967 0
charles.brooker@sydney.edu.au
Contact person for scientific queries
Name 71968 0
A/Prof Charles Brooker
Address 71968 0
Michael J Cousins Pain Management and Research Centre
Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065
Country 71968 0
Australia
Phone 71968 0
+61294631500
Fax 71968 0
+61294631050
Email 71968 0
charles.brooker@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary