TMR in the prevention of neuroma related limb pain after BKA
Research type
Research Study
Full title
A single-blinded, two-armed, randomized clinical trial of targeted muscle reinnervation (TMR) in the prevention of neuroma related pain after below knee amputation.
IRAS ID
230344
Contact name
Norbert Kang
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust
Clinicaltrials.gov Identifier
not applicable, not applicable
Duration of Study in the UK
2 years, 7 months, 8 days
Research summary
Broadly speaking, there are two types of troublesome pain that may be suffered by patients after a below knee amputation. The first is called neuroma pain which is related to the formation of a disorganised and sensitive mass of nerve endings and scar tissue at the end a nerve stump. The second is called phantom limb pain in which the patient continues to perceive pain in the (now absent) parts of the amputated limb. The two are related but separate and both are difficult to treat. Therefore, some patients with neuroma pain have no phantom limb problems. Equally, some patients with intense phantom limb pain have no neuroma pain of note.
Neuroma pains affect 80% of amputees but are only troublesome and persistent in 10-30% of patients. Similarly, phantom limb sensations affect 100% of patients after amputation but are only troublesome in 10-30% of patients. The many different modes of treatment that have been employed to treat both neuroma and phantom pain are testament to the (currently) poor understanding of the mechanisms underpinning both. As a result, patients often have to try many different modalities before finding a particular method that brings relief. The treatments currently available include both drugs, surgery and psychological techniques (including hypnotherapy and acupuncture).
In this study, we hope to study the effects of a relatively new surgical technique called Targeted Muscle Reinnervation (TMR) on the development of both neuroma and phantom pain sensations after below knee amputation. The study will enrol patients into two groups. Group 1 will have a standard below knee amputation. Group 2 will undergo below knee amputation and TMR surgery. We will then follow these two groups for at least 1 year to monitor them for the development of neuroma or phantom limb pain to determine the effect of TMR surgery.
REC name
London - Surrey Research Ethics Committee
REC reference
18/LO/0390
Date of REC Opinion
4 Sep 2018
REC opinion
Further Information Favourable Opinion