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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Ursula Ann Bobi
+44 (0)121 415 9128
u.a.w.bobi@bham.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - The utility of frequency-modulated electromagnetic neural stimulation as a third-line treatment in patients with painful diabetes-related peripheral neuropathy
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The utility of frequency-modulated electromagnetic neural stimulation as a third-line treatment in patients with painful diabetes-related peripheral neuropathy

Recruiting

Open to: All Genders

Age: Adult

Sheffield London Ipswich Carmarthen Birmingham Nuneaton Liverpool Manchester Preston Cardiff

Medical Conditions

Painful diabetes-related peripheral neuropathy

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Diabetes mellitus (DM) is very common in the UK and globally and is a major healthcare 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, reaching 4.7 million in 2018, costing the NHS at least £10 billion a year, or 10% of the total NHS budget. The number of people living with DM is expected to reach 5 million in 2025 and 5.5 million in 2030, and the cost to the NHS is likely to increase significantly with this increased prevalence. Painful diabetes-related peripheral neuropathy (PDPN, damage to the nerves caused by high blood sugar levels) is a serious complication affecting 20-26% of patients with DM. PDPN has a major impact on quality of life, mood, sleep and relationships. This study aims to evaluate the clinical and cost-effectiveness of FREMS (frequency rhythmic electrical modulated system) in adults with PDPN.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

31 Jan 2023 30 Sep 2025

Participants are randomly allocated to receive 10 sessions of either transcutaneous electrical nerve stimulation (TENS) or FREMS treatment for 35 minutes each session. Follow-up is then up until 6 months.


Patients aged 18 years and over with diabetes mellitus and neuropathic pain affecting both feet for at least 3 months or taking pain medication for neuropathic pain for at least 3 months

You can take part if:


Current inclusion criteria as of 15/04/2025:
1. Aged ≥18 years
2. Neuropathic pain affecting both feet for ≥3 months or taking pain medication for neuropathic pain for ≥3 months
3. Mean pain score ≥4 on the daily NRS ≤4 weeks prior to randomisation
4. Douleur Neuropathique 4 (DN-4) questionnaire score ≥4/10 at screening to confirm the diagnosis of bilateral distal symmetrical neuropathic pain [70]
5. Diabetes-related neuropathy based on the Michigan Neuropathy Screening Instrument (MNSI) (MNSI questionnaire scored ≥7 or examination scored >2) [71, 72]
6. HbA1c <108 mmol/mol or 12% taken (within last 2 months).
7. Have tried at least two anti-neuropathic drugs from two different classes for PDPN
8. Willing and able to comply with the study schedule and be available for the treatment duration
9. Able to give


You may not be able to take part if:


Current exclusion criteria as of 15/04/2025:1. Non-diabetic neuropathies2. Currently using TENS for PDPN3. History of epilepsy4. Other painful medical conditions where the pain is significantly more severe than their PDPN pain (patients will not be excluded if the pain is transient in nature)5. Major amputations of the lower limbs6. Active diabetic foot ulcers7. Active malignancy8. Patient has a pacemaker, defibrillator or neurostimulator9. Pregnancy

Previous exclusion criteria:1. Non-diabetic neuropathies2. Currently using TENS for PDPN3. History of epilepsy4. Other painful medical conditions where the pain is significantly more severe than their PDPN pain (patients will not be excluded if the pain is transient in nature)5. Major amputations of the lower limbs6. Active diabetic foot ulcers7. Diagnosed malignancy8. Pacemakers, defibrillator or neurostimulator9. Pregnancy


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Hallamshire Hospital
    Glossop Road
    Sheffield
    S10 2JF
  • Kings College Hospital
    Mapother House De Crespigny Park Denmark Hill
    London
    SE5 8AB
  • Ipswich Hospital
    Heath Road
    Ipswich
    IP4 5PD
  • Hywel Dda University Lhb
    Corporate Offices, Ystwyth Building Hafan Derwen St Davids Park, Jobswell Road
    Carmarthen
    SA31 3BB
  • Heartlands Hospital
    Bordesley Green East Bordesley Green
    Birmingham
    B9 5ST
  • George Eliot Hospital
    College Street
    Nuneaton
    CV10 7DJ
  • The Walton Centre
    Lower Lane Fazakerley
    Liverpool
    L9 7LJ
  • Manchester Diabetes, Endocrine and Metabolism Centre
    Manchester Royal Infirmary Cobbett House Oxford Road
    Manchester
    M13 9WL
  • Minerva Health Centre
    Lancashire and South Cumbria NHS Foundation Trust Sceptre Way Walton Summit
    Preston
    PR5 6AW
  • University Hospital of Wales
    Cardiff and Vale University Local Health Board Woodland House
    Cardiff
    CF14 4HH

The researchers do not expect any safety issues or risks for the participants. The only risk associated with either intervention is in the potential for soreness at the point of application of the adhesive patches during and shortly after treatment; this risk remains the same for both arms. Offering the study to potential participants may prolong the clinic visit. The time taken for patients to receive their treatment can also be deemed as a potential burden but this additional time was felt to be within acceptable limits by patients and patient society representatives. Both treatments could give some pain relief to patients. Participants will have the potential opportunity to try a new therapy before it is generally available.

Ms Ursula Ann Bobi
+44 (0)121 415 9128
u.a.w.bobi@bham.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Birmingham and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC).




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Read full details for Trial ID: ISRCTN11665378

Or CPMS 53965

Last updated 15 April 2025

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