None listed
Conditions
Brief summary
Multicentre randomised double-blinded sham-lesion control trial to evaluate the role and effectiveness of pulsed radiofrequency treatment (PRF) of a peripheral nociceptive trigger (i.e. neuroma) in the management of phantom and residual limb pain. Participants will be recruited through the Victorian Artificial Limb Program Outpatient Clinic at Royal Park Campus RMH. Eligible patients will undergo perineuromal injections with local anaesthetic performed under ultrasound. Responses will be recorded as positive if the participant experiences a decrease in pain intensity of at least 50%. Patients with a positive response will proceed to PRF or placebo assigned in a random manner. Participants will be followed up at 1 week, 4 weeks and 3 months. Measures of pain intensity (BPI), pain quality (SF MacGill Pain Questionaire), physical functioning (BPI), emotional functioning (DASS), patients global rating of improvement and satisfaction (PGIC), health-related quality of life, prosthetic use (TAPES-R), healthcare utilisation will be obtained at each review.
Interventions
Pulsed Radiofrequency Treatment (PRF)
This will be delivered via percutaneous radio frequency needle which will be inserted under ultrasound guidance with the tip positioned next to the neuroma.
PRF will be performed at a frequncy of 2Hz, 20msec pulses in a 1 second cycle of 120 seconds duration at a temperature of 42 C. This will be repeated three times whilst the needle is rotated until a 360 degree area of neuroma is covered.
Before the needle is removed, a 2mL mixture of 1.5mL 1% lignocai
Pulsed Radiofrequency Treatment (PRF) This will be delivered via percutaneous radio frequency needle which will be inserted under ultrasound guidance with the tip positioned next to the neuroma. PRF will be performed at a frequncy of 2Hz, 20msec pulses in a 1 second cycle of 120 seconds duration at a temperature of 42 C. This will be repeated three times whilst the needle is rotated until a 360 degree area of neuroma is covered. Before the needle is removed, a 2mL mixture of 1.5mL 1% lignocaine and 0.5mL Celestone will be injected around the neuroma. The estimated total duration of the procedure will be 30 minutes. There will be one treatment session.
Sponsors
The Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria will be age >18, at least 1 major amputation above the ankle, the presence of persistent residual limb or phantom limb pain for at least 3 months with a peripheral trigger clinically +/- ultrasound (US) confirmation
Exclusion criteria
Exclusion criteria are previous radiofrequency denervation of neuroma, contraindications to steroid, local anaesthetic and sedative agent administration, bleeding dyscrasias, immunosuppression, concomitant active infection of the procedure site or systemic infection, fragile residual limb skin prone to non-healing and breakdown, and severe cognitive impairment
Outcome results
None listed