FREMS-PDPN

This study will evaluate if a nerve stimulation device can reduce pain from the nerve damage caused by diabetes.

The study will compare two different forms of stimulation to assess which helps nerve pain better and for longer.

• FREMS: Frequency-modulated electromagnetic neural stimulation
• TENS: Transcutaneous electrical nerve stimulation

It is being carried out by a team of researchers at the University of Birmingham in collaboration with The Walton Centre NHS Foundation Trust and funded by the NIHR (National Institute for Health and Care Research).

• Aged 18+
• Diagnosed with diabetes (any type)
• Have painful peripheral neuropathy (impaired foot sensation) despite taking medication for it

• Manchester Royal Infirmary
• The Walton Centre
• The Royal Preston Hospital

Taking part will involve:

• Attending a screening appointment to assess suitability, including online consent and 7-day pain diary

If suitable for the study:

• Attending an initial clinic appointment which will include a range of tests (eg blood sample, blood pressure, foot examination, body measurements etc) as well as questionnaires about your pain, sleep, mood and general health and wellbeing
• 10 treatment sessions* over a two-week period (approx. 35 minutes each)
• Keeping a pain diary for up to six months
• Follow up appointments will take place 3 and 6 months after treatment has ended.

Up to £20 travel expenses for each clinic visit are available. Participants will receive a £25 voucher at 3 months.

* Participants will be randomly assigned to one of two groups to receive either the FREMS or TENS treatment.

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