A randomised double blind placebo controlled trial of radiofrequency neurotomy for the treatment of lumbar zygapophysial joint pain

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12608000365369
• Date of registration: 25/07/2008
• Prospective Registration: Yes
• Primary sponsor: Dr. Paul Verrills
• Public title: A randomised double blind placebo controlled trial of radiofrequency neurotomy for the treatment of lumbar zygapophysial joint pain
• Scientific title: A randomised double blind placebo controlled trial of radiofrequency neurotomy for the treatment of lumbar zygapophysial joint pain
• Date of first enrolment: 01/11/2008
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12608000365369.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr. Paul Verrills

• Name: Adele Barnard

Key inclusion & exclusion criteria

Inclusion criteria: 1. Low back pain for a duration of more than 3 months
2. Pain severity of at least 5/10 on a visual analogue scale, which is sufficient to warrant invasive treatment
3. Complete, or vitually complete, relief of pain in response to controlled, medial branch blocks performed on at least two occasions.
4. Up to, but not exceeding two sympathetic zygapophysial joints per side
Exclusion criteria: 1. Unable to provide informed consent
2. Unable to complete the assessment instruments
3. Anatomical abnormalities that might interfere with the safe conduct of the treatment
4. Any illness or disorder that might interfere with the safe conduct of treatment
5. Overt, clinically evident psychological disturbance, such as severe depression, drug dependence, or drug-seeking behaviour that might interfere with the assessment or response to treatment
6. Concomitant cervical, thoracic, hip, or other pain, of an intensity greater than 2/10 (on the visual analogue scale (VAS))or otherwise, which may interfere with the assessment or response to treatment

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Lumbar zygapophysial joint pain;
Lumbar zygapophysial joint pain

Musculoskeletal - Other muscular and skeletal disorders

Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

Neurological - Other neurological disorders

Intervention(s)

Radiofrequency Neurotomy (RFN) involves the insertion of an insulated needle electrode (probe) with an exposed tip into contact or close proximity to a target nerve under local anaesthetic and radiological control. A RF generator applies current to raise the temperature of the exposed tip of the probe to 80-85 degrees celcius and maintained at that level for 90 seconds, in order to coagulate the target nerve and disrupt the conduction of nociceptive (pain producing) impulses along that nerve. This outcome is acheived in one single treatment.

Primary Outcome(s)

The objective is to determine the efficacy of lumbar medial branch neurotomy, for proven lumbar zygapophysial joint pain. The primary outcome measure will be relief of pain. This will be done by self-assessment using a numerical pain rating scale and by doctor assessments at the follow up visits.[A pre-treatment assessment will be made, whilst follow up assessments will be scheduled at 3, 6, 9 and 12 months following treatment.]

Secondary Outcome(s)

Comparison between pre treatment and post treatment disability and depression scores. These outcome measures will be measured by patient and doctor answered questionnaires. These questionnaires will consist of the Quality of Life (AQoL), SF-36, Roland-Morris diability scale and the patient-specified functional outcome measure questionnaire.[A pre-treatment assessment will be made, whilst follow up assessments will be scheduled at 3, 6, 9 and 12 months following treatment.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

International Spinal Intervention Society

Secondary Sponsor(s)

Adele Barnard

Ethics review

Status: Approved
Approval date:
Contact:

The Avenue Ethics Committee