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Evaluating the efficacy of FREMS (Frequency Rhythmic Electrical Modulated System) in patients with painful diabetic peripheral neuropathy (PDPN, painful feet from nerve damages caused by diabetes)

The FREMS-PDPN Study Participant Information Animation

Diabetes Mellitus (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.

With an increasing prevalence of DM, the prevalence and burden of PDPN is likely to increase further over the next decade, which will pose a major treatment and financial challenge.

Please watch our animation to find out more about the FREMS-PDPN study.


PDPN affects a quarter of people with diabetes and 70% of sufferers have moderate-to-severe foot pain. This pain results in in sleep disruption, poor quality of life (QoL), unemployment and depression. The average health care cost for each patient with PDPN in the UK was estimated to be £2,511 per year, which increases with greater pain severity. The burden of PDPN is likely to increase as diabetes becomes more common.

NICE guidance 173 recommended certain medications as initial treatments for PDPN. However, using these medications results in 50% reduction in pain in one third of patients at best. These medications also have multiple side effects such as nausea, sedation, dizziness, dry mouth, weight gain, falls, constipation and more.

Beyond these drugs, there are no NICE recommended treatments. As a result, many patients receive opioids (43%), which has many unwanted side effects including addiction. Hence, there is a clear need to identify an effective, safe, well-tolerated, non-invasive intervention that is good value for money in those who fail to respond to NICE recommended treatments. This could reduce medications and opioid use & improve QoL.

Taking Part

Find out more about taking part in the study

About the Study

Learn more about the study

Contact Us

Get in touch with the study team

MEDICAL TRIAL study logo

Birmingham Clinical Trials Unit
Public Health Building
University of Birmingham
Birmingham B15 2TT

+44 (0)121 415 9128

[email protected]


This study is funded by the National Institute for Health Research (NIHR) Heath Technology Assessment programme (project reference NIHR133599). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

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