Qutenza® for amputation stump hypersensitivity and phantom limb pain.
Research type
Research Study
Full title
Treatment of amputation stump hypersensitivity and phantom limb pain with high-concentration capsaicin patch Qutenza®: a clinical and functional MRI study.
IRAS ID
159555
Contact name
Praveen Anand
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Following limb amputation, many patients complain of pain and increased sensitivity (soreness) in the amputation stump. In addition, more than 50% patients feel pain in the limb as if it was still attached to the body, known as Phantom Limb Pain.
The pain and hypersensitivity in the amputation stump makes it difficult for the patient to wear a prosthetic limb, thereby affecting mobility and rehabilitation. The phantom limb pain can be severe and distressing, for which current treatments have limited and variable efficacy.
The mechanisms by which patients develop amputation stump and phantom limb pain are not fully understood, but damaged nerve fibers within the amputation stump result in stump pain, and changes in the brain maps reflect the degree of phantom limb pain.
Qutenza® (capsaicin 8% patch) has been approved in the EU to treat peripheral neuropathic pain (pain arising from nerve damage or dysfunction), including amputation stump neuropathic pain. A single 60 minute application of Qutenza® skin patch can provide pain relief for up to 3 months, without the side-effects seen with other pain treatments. The patches contain capsaicin, the naturally occuring ingredient in chilli peppers that gives them their pungency and heat sensation.
The present study will relate the effect of a single application of a Qutenza® patch, used as licensed and monitored according standard practice, to any changes of physiological sensory tests in the amputation stump, and brain sensory maps using functional MRI scans.
The study will be conducted at a single site with experience of treatment of patients with the Qutenza® patch and the tests involved.
Participation in the study will involve baseline sensory tests and fMRI brain scan, which will be repeated after standard Qutenza® application. This study will advance the understanding of phantom limb pain, and mechanisms underlying the effect of Qutenza® treatment.REC name
London - Fulham Research Ethics Committee
REC reference
15/LO/0566
Date of REC Opinion
5 May 2015
REC opinion
Further Information Favourable Opinion