FREMS-PDPN
Research type
Research Study
Full title
The Utility of Frequency-Modulated Electromagnetic Neural Stimulation (FREMS) as a Third Line Treatment in Patients with Painful Diabetes-Related Peripheral Neuropathy: A Randomised Controlled Trial.
IRAS ID
316524
Contact name
Bernhard Frank
Contact email
Sponsor organisation
University of Birmingham
ISRCTN Number
ISRCTN11665378
Duration of Study in the UK
3 years, 3 months, 28 days
Research summary
Diabetes (DM) is very common in the UK and globally and is a major health care challenge for the NHS. Diabetes UK announced that the number of people living with DM in the UK has more than doubled over the last 20 years.
Painful Diabetes-related Peripheral Neuropathy (PDPN) is a serious complication affecting 20-26% of patients with DM. Side effects of PDPN include reduced QOL, sleep disruption, and mood changes.
The mainstay of treatment is pharmacotherapy, although there is moderate evidence for the efficacy of the recommended drug treatments available, often leading to opioid use. Side effects and drug withdrawal are common.There is a clear gap in the treatment pathway of patients with PDPN regarding a safe, non-invasive, clinically effective and cost effective third line treatment that is safe with an acceptable safety/side-effect profile. Treatment with a Frequency-Modulated Electromagnetic Neural Stimulation (FREMS) machine may be able to address this gap: FREMS may offer lasting and non-invasive pain relief for PDPN. FREMS treatment may have the potential to reduce the need for pharmacotherapy (particularly opioids) and its associated risks.
FREMS-PDPN is a pragmatic, multi-centre, 2-arm, parallel group, double blind, sham controlled, randomised trial of patients with PDPN. It aims to evaluate the clinical and cost-effectiveness of FREMS for adults with PDPN.
The primary outcome (pain severity) is measured at 3 months post-randomisation with follow up until 6 months. The administering team, the participant and all researchers will be blinded to treatment allocation.
A number of other key outcomes such as impact on sleep, quality of life, mood and medication use will be assessed.FREMS will have an internal pilot phase with stop/go criteria. 356 patients will be randomised to either FREMS + standard care or TENS + standard care. Patients will receive 10 sessions of their allocated treatment over a two week period.
REC name
London - Bromley Research Ethics Committee
REC reference
22/LO/0683
Date of REC Opinion
28 Nov 2022
REC opinion
Further Information Favourable Opinion