FREMS -PDPN STUDY (CPMS 53965, IRAS 316524)

UPDATED - 22/08/2024

Study 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.

Inclusion  Criteria:

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 for one week 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. 

5. Diabetes-related neuropathy based on the Michigan Neuropathy Screening Instrument (MNSI) (MNSI questionnaire scored > = 7 or examination scored > 2). 

6. HbA1c < 108 mmol/mol or 12% (within the last 2 months).  

7. Have tried at least two 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 written informed consent.

Exclusion Criteria:

1. Non-diabetic neuropathies. 

2. Currently using TENS for PDPN. 

3. History of epilepsy. 

4. 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 limbs. 

6. Active diabetic foot ulcers. 

7. Diagnosed malignancy. 

8. Pacemakers, defibrillator or neurostimulator.

9. Pregnancy.

Study Resources

Access for the SystmOne and EMIS study resources can be requested below.

For further guidance on using the resources, please refer to the guidance documents and further useful information on the PRIDES page.

The searches have been created with the study specific inclusion and exclusion criteria. 

If you require any further information or help, please contact the IT Specialists:

Jodie Button – jodie.button@nihr.ac.uk

James Baslington – james.baslington@nhs.net

Disclaimer:

Please note the resources provided are designed to assist with the identification of potentially suitable patients and to appropriately code these patients if required.

These resources have been developed based on the criteria provided by the relevant study team and whilst every effort has been made to make them universally implementable they rely on read codes and the data stored in the individual practice's clinical system. These resources are intended to assist with identification but should be used in conjunction with clinical oversight and a clear understanding of the study parameters.

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