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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001208392
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
15/09/2026
Date registered
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30/09/2026
Date last updated
Help: Date last updated
30/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
30/09/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
RELIEF trial – Radiofrequency ablation for chronic low back pain, a placebo controlled Randomised trial
Scientific title
RELIEF trial – Effect of radiofrequency ablation on average intensity of chronic low back pain in adults aged 40 years and over, a placebo controlled Randomised trial
Additional trial identifiers [1] 318510 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
RELIEF
Related trial records

Health condition
Health condition(s) studied:
Chronic Low Back Pain 343623 0
Lumbar Facet Joint Pain 343624 0
Condition category
Condition code
Musculoskeletal 339728 339728 0 0
Other muscular and skeletal disorders
Musculoskeletal 339729 339729 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Eligible participants will be randomised to either RFA or placebo intervention at a participating hospital pain clinic. Randomisation will be stratified by treating physicians in a 1.5:1 ratio of RFA to placebo. Participants randomised to the RFA group will receive radiofrequency ablation of the medial branches innervating the lumbar facet joints.

This involves participants laying face down on an x-ray table with sedation/anaesthesia and local anaesthetic used as clinically appropriate. Specialised RFA needles are positioned next to the targeted lumbar nerves using fluoroscopy (X-ray) guidance. Motor testing is performed to confirm safe needle positioning, with needles repositioned if required. Radiofrequency energy is then used to heat the targeted nerves creating a controlled lesion. The procedure is then complete and participants are able to return home the same day.

The intervention is a single procedure, Participants will see the treating pain doctor before and after the intervention based on usual clinical practice, usually one appointment pre and post procedure. Study assessments will be completed at 6 weeks, 3, 6 and 12 months.

The procedure is performed by a Specialist Pain Medicine Physician trained in lumbar RFA, supported by a trained radiofrequency machine operator.

Adherence is monitored through fluoroscopic images documenting correct delivery of the intervention, and by an unblinded study team member reviewing generator settings and images of lead placement indicating which intervention was delivered.
Intervention code [1] 335357 0
Treatment: Other
Description of the comparator or control
Participants randomised to the placebo control group will receive nearly the same procedures as for the experimental RFA group, including placement of the needle and testing to ensure position adjacent to the nerve, however there will be no energy applied to ablate the targeted nerve. The RF generator will still be activated to replicate the sounds and time of a normal ablation; however no energy will be applied to the needles in the participant.
Control group
Placebo

Outcomes
Primary outcome [1] 346901 0
Average Low Back Pain (LBP) intensity in the past seven days
Timepoint [1] 346901 0
Measured at 3 months post intervention
Secondary outcome [1] 468051 0
Condition-specific disability
Timepoint [1] 468051 0
Measured at Baseline, 6 weeks, 3, 6 and 12 months post intervention
Secondary outcome [2] 468052 0
Average Low Back Pain (LBP) in the past seven days
Timepoint [2] 468052 0
Baseline, 6 weeks, 6 months and 12 months post intervention
Secondary outcome [3] 468053 0
Quality of life
Timepoint [3] 468053 0
Baseline, 6 weeks, 3, 6 and 12 months post intervention
Secondary outcome [4] 468054 0
Pain Self-Efficacy
Timepoint [4] 468054 0
Baseline. 6 weeks, 3, 6 and 12 months post intervention
Secondary outcome [5] 468055 0
Opioid use in the four weeks (converted to morphine equivalent dose)
Timepoint [5] 468055 0
Baseline, 6 weeks, 3, 6 and 12 months post intervention
Secondary outcome [6] 468056 0
Adverse events possibly including: Bruising or tenderness at the needle insertion site Temporary worsening of usual back pain Muscle spasm in the back Temporary loss of sensation in the treated area Increased sensitivity of the skin (burning, hypersensitivity, or "sunburn-like" discomfort) Dizziness, light-headedness, or feeling faint after the procedure Allergic reaction to medications, antiseptics, local anaesthetic, or dressings (rare) Skin burns from the heat generated by the procedure (very rare) Weakness in nearby muscles (usually temporary and uncommon) Damage to nearby blood vessels or tissues (very rare) Failure to obtain pain relief or recurrence of pain over time
Timepoint [6] 468056 0
Intervention, 6 weeks, 3, 6 and 12 months post intervention
Secondary outcome [7] 468057 0
Perceived recovery
Timepoint [7] 468057 0
6 weeks, 3, 6 and 12 months post intervention

Eligibility
Key inclusion criteria
• Adults greater than or equal to 40 years of age
• LBP for greater than or equal to 3 months, predominantly axial lumbar pain
• Positive Medial Branch Block (MBB) greater than or equal to 50% pain reduction post MBB (on 0-10 point-scale)
• Numerical score for usual pain in the last week greater than or equal to 5 (on 0-10 point-scale, prior to MBB)
• Not having recovered after at least 3 months of conservative treatment (e.g. exercises, physiotherapy, analgesics)
• Provision of written informed consent
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Suspected serious pathologies (e.g., malignancy, fracture, infection)
• Neurological deficit suggestive of radiculopathy as the main complaint
• Unable or unwilling to undergo RFA
• Previous lumbar spine surgery within the previous 12 months
• Previous lumbar RFA
• Previous lumbar fusion involving the spinal levels where lumbar RFA is considered
• Pregnancy or suspected pregnancy or comorbid conditions that contra-indicate intervention
• Cognitive impairment that prevents engagement with study procedures

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed via a secure REDcap module hosted by The George Institute and the randomisation schedule will use randomly permuted blocks of size 5 and 10 and will be stratified by treating clinician to ensure that potential variations in care are balanced across the two groups. Allocation to RFA or placebo will be done at a 1.5:1 ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2026
Actual
Date of last participant enrolment
Anticipated
31/12/2029
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
321
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 322773 0
Government body
Name [1] 322773 0
NHMRC
Country [1] 322773 0
Australia
Funding source category [2] 323030 0
Commercial sector/Industry
Name [2] 323030 0
Ramsay Health
Country [2] 323030 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The George Institute for Global Health
Address
Country
Australia
Secondary sponsor category [1] 325972 0
None
Name [1] 325972 0
Address [1] 325972 0
Country [1] 325972 0
Other collaborator category [1] 284102 0
University
Name [1] 284102 0
UNSW
Address [1] 284102 0
Country [1] 284102 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321215 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 321215 0
Ethics committee country [1] 321215 0
Australia
Date submitted for ethics approval [1] 321215 0
19/05/2026
Approval date [1] 321215 0
09/09/2026
Ethics approval number [1] 321215 0

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

Contacts
Principal investigator
Name 153030 0
Prof Manuela Ferreira
Address 153030 0
The George Institute for Global Health, Level8/55 Botany St, Randwick NSW 2031
Country 153030 0
Australia
Phone 153030 0
+61 280524300
Fax 153030 0
Email 153030 0
[email protected]
Contact person for public queries
Name 153031 0
Manuela Ferreira
Address 153031 0
The George Institute for Global Health, Level8/55 Botany St, Randwick NSW 2031
Country 153031 0
Australia
Phone 153031 0
+61 280524300
Fax 153031 0
Email 153031 0
[email protected]
Contact person for scientific queries
Name 153032 0
Manuela Ferreira
Address 153032 0
The George Institute for Global Health, Level8/55 Botany St, Randwick NSW 2031
Country 153032 0
Australia
Phone 153032 0
+61 280524300
Fax 153032 0
Email 153032 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.