Sensory retraining for phantom limb pain
Research type
Research Study
Full title
An investigation of the efficacy of a novel sensory discrimination training device for the management of phantom limb pain: A randomised, single-blind placebo-controlled trial. [PHANTOM RELIEF Trial]
IRAS ID
250337
Contact name
Cormac Ryan
Contact email
Sponsor organisation
Teesside University
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 27 days
Research summary
80% of people who have had an amputation still feel pain in the limb that has been amputated - Phantom limb pain (PLP).
We have developed a new device to help people with PLP. People with PLP have an abnormal blueprint of their limb in their brain. The blueprint no longer matches the physical limb. This may lead to pain. The device aims to normalise this blueprint by training individuals to recognise different patterns of mild, non-harmful electrical pulses applied to the skin of the residual limb. This is known as Sensory Discrimination Training (SDT). The theory is that improving the person’s ability to distinguish between the different patterns changes the brains blueprint, through neuroplasticity, so it better matches the actual limb, reducing pain.
To date, research studies investigating SDT, have used manual techniques/devices operated by clinicians. This is costly and not widely available. So, we have developed a device that patients can use themselves at home, to make SDT available for many more patients, and save NHS costs.
This study will investigate the device’s effect on PLP compared with a placebo/sham device. The study will be undertaken remotely. Communications will be via email/SMS messages, telephone, or video conferencing platforms. One hundred people with PLP will be recruited from the NHS, and the general public, and randomised to receive either the active or placebo device. Participants will be trained to use their device and research assistants will keep in regular contact during a 3-week home treatment. We will measure pain and function at baseline, after treatment, and at 3 months follow-up. Twelve participants will also be invited to a one-to-one interview to give their experience of the acceptability and usability of their device.REC name
North of Scotland Research Ethics Committee 2
REC reference
23/NS/0085
Date of REC Opinion
11 Aug 2023
REC opinion
Favourable Opinion