Radiofrequency Treatment of Phantom and Residual Limb Pain in Persons with a Lower Limb Amputation: A Randomised Double Blinded Control Trial

Not Applicable

• Conditions: Phantom and Residual Limb Pain in Persons with a Lower Limb Amputation; Anaesthesiology - Pain management; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12613000549729
• Lead Sponsor: The Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression Anxiety Stress Scale (DASS)[1 week, 4 weeks, 12 weeks post intervention];Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R)[1 week, 4 weeks, 12 weeks post intervention];Brief Pain Inventory (BPI) including Verbal Numerical Rating Score (VNRS) [1 week, 4 weeks, 12 weeks post intervention]

Secondary Outcome Measures

Name	Time	Method
The Patient Global Expression of Pain (PGIC) Scale[1 week, 4 weeks, 12 weeks post intervention];Short-Form MacGill Pain Questionnaire [1 week, 4 weeks, 12 weeks post intervention];Healthcare Utilisation (Information about medical attendance/s will be asked and recorded) [1 week, 4 weeks, 12 weeks post intervention]