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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 .

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000622303
Enrollment
120
Registered
2017-05-01
Start date
2006-02-01
Completion date
2009-07-31
Last updated
2017-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Royal North Shore Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026