T-CLAN study
Research type
Research Study
Full title
transcutaneous laser for management of amputation neuroma pain (T-CLaN)
IRAS ID
264813
Contact name
Ernest Azzopardi
Contact email
Sponsor organisation
R&D Dept, SB UHB
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Neuroma pain is a major cause of morbidity. Surgical success is only around 50%, but actual functional improvement may only be as high as 12.5%, with significant potential morbidity and cost. Published small case series have explored the use of laser to stop conduction of pain signalling through the nerve feeding the neuromas reported no return of symptomatology at 56 months. Single bare fiber technology allows even smaller fluences to be used whilst targeting the nerve effectively. This modality of treatment is well-estsablished practice in other aspects of plastic surgery, used successfuly and with no/minimum mortality in other areas such as cosmetic surgery etc. This study therefore aims to replicate this success through exploring the use of single bare fiber laser in the management of neroma pain from post reduction amputation neuromas. The study will be conducted in a consecutive, prospective series of 10 patients. Patients will be referred through the Wales Peripheral Nerve Multidisciplinary team based in house at SBUHB Morriston Hospital. The study aims to include adult patients in whom medical and surgical intervention has been maximised, contraindicated, or refused. Inclusion necessitates diagnosis with targetable nerve feeding the neuroma under ultrasound guidance. Following diagnostic upstream injection of local anaesthetic, said nerve will be identified under ultrasound and laser will be used downstream. Likert and mobility scores before and after the intervention will be used to monitor outcomes. Neuroma size will be measured by ultrasound. Follow up will be arranged within their normal clinics for up to 24 months. Based on previous small scale case studies/series laser treatment has the potential to become a low risk office-based procedure offering long-term pain reduction.
REC name
London - Surrey Research Ethics Committee
REC reference
20/PR/0379
Date of REC Opinion
30 Oct 2020
REC opinion
Further Information Favourable Opinion