Frequency Rhythmic Electrical Modulation System (FREMS) to alleviate painful diabetic peripheral neuropathy: A pilot, randomised controlled trial (The FREMSTOP study)

Crasto, Winston; Altaf, Q.; Selvaraj, Dhiraj Ravindran; Jack, Bukola; Patel, Vinod; Nawaz, Sarfaraz; Murthy, Narasimha; Sukumar, Nithya; Saravanan, Ponnusamy; Tahrani, Abd

doi:10.1111/dme.14710

Cited by 5 publications

(5 citation statements)

References 39 publications

(73 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, at least, our survey provides data that can justify an RCT assessing the role of FREMS as a third line treatment option in the management of PDPN and also provide the evidence for FREMS efficacy in a real-world setting. The strengths of our study include a relatively large number of participants compared to other studies in the field; 15 a well characterised cohort in that they have failed previous pharmacotherapy and do not have other causes of pain such as malignancy or peripheral vascular disease and we measured the impact on QOL, TDS and medications use.…”

Section: Discussionmentioning

confidence: 99%

Treatment of Painful Diabetic Neuropathy Using Frequency Rhythmic Electro Magnetic Neural Stimulation (FREMS); Effectiveness in Daily Practice

Imholz¹,

Heijster²,

Tahrani³

et al. 2023

DMSO

View full text Add to dashboard Cite

Background Painful diabetic peripheral neuropathy (PDPN) is common and difficult to treat with limited treatment options. We assessed the efficacy of frequency rhythmic electromagnetic neural stimulation (FREMS) in patients with PDPN. Methods An uncontrolled prospective survey of patients with PDPN and pain despite at least two lines of pharmacotherapy. The primary outcome, 50% reduction in pain scores at 1 and/or 3 months post FREMS. FREMS was applied to both legs below the knees using 4 sets of electrodes per leg; the treatment consisted of 10 sessions of 35 min applications given over 14 days. FREMS was repeated every 4 months and patients were followed up for 12 months. Pain was assessed using the neuropathic pain symptom inventory (NPSI) and quality of life (QOL) by the EQ-5D. Results Out of 336 subjects, 248 patients met the inclusion criteria (56% men), average age and diabetes duration were 65 and 12.6 years respectively. FREMS was associated with a median decrease NPSI of 31% at M1 (range −100;+93%), and a median decrease of −37.5% at M3 (range −100;+250%). The 50% reduction in pain was reached in 80/248 (32.3%) and 87/248 (35.1%) after M1 and M3 respectively. The change in NPSI was accompanied by a decrease in self reported use of opiates of >50%. Conclusion FREMS treatment was associated with a significant reduction in pain severity over a three months period in patients who did not have adequate response to pharmacotherapy. Randomised (sham)-controlled trials examining the role of FREMS as a treatment for PDPN in non-responders to pharmacotherapy are needed.

show abstract

Section: Discussionmentioning

confidence: 99%

Treatment of Painful Diabetic Neuropathy Using Frequency Rhythmic Electro Magnetic Neural Stimulation (FREMS); Effectiveness in Daily Practice

Imholz¹,

Heijster²,

Tahrani³

et al. 2023

DMSO

View full text Add to dashboard Cite

show abstract

“…In 2021, Crasto et al conducted a pilot, randomized controlled trial in the United Kingdom in patients with dual neuropathic pain treatments recruited from primary and secondary care [10]. Participants were randomized to FREMS and usual care (n = 13) or usual care only (n = 12).…”

Section: Discussionmentioning

confidence: 99%

The 8-Week Efficacy of Frequency Rhythmic Electrical Modulated System (FREMS) as an Add-on Therapy in the Treatment of Symptomatic Diabetic Peripheral Polyneuropathy

Gorczyca-Siudak

Dziemidok

2022

IJERPH

View full text Add to dashboard Cite

Background: Frequency Rhythmic Electrical Modulated System (FREMS) is a method of transcutaneous treatment based on frequency-modulated electromagnetic neural stimulation. Its efficacy in neuropathic pain in diabetes mellitus still lacks enough research. Methods: A randomized, single-blind, sham-controlled trial in individuals with symmetric distal polyneuropathy (SDPN) as an add-on therapy compared to standard therapy with alpha-lipoic acid. Participants were randomized to FREMS and standard of care (SOC) versus SOC only. The primary outcome was a change from baseline in perceived pain assessed by visual analogue scale (VAS) after 5 days of treatment and after 8 weeks of follow-up between treatment groups. Results: After 5 days of treatment, patients in both groups felt significant reduction in pain as measured by VAS, although only FREMS treatment lasted for 8 weeks and induced a significant improvement in quality of life measured by EuroQol 5-Dimension 5-Level (EQ-5D-5L) and Clinical Global Impression of Change (CGI-C) questionnaires. There were non-significant differences observed in the instrument pain assessment. No relevant side effects were recorded during the study. Conclusions: FREMS as an addition to alpha-lipoic acid therapy occurred to be a beneficial method of treatment in individuals with SDPN and was associated with improvements in pain severity, quality of life and clinical global improvement.

show abstract

“… 65 FREMS is another non-invasive treatment which applies series of electrical pulses through electrodes attached to a patient’s lower limbs. 67 Two RCTs have demonstrated improvements in pain with FREMS, 68 , 69 with a recent pilot RCT study (The FREMSTOP Study) finding that FREMS could be integrated into the treatment algorithm for patients who have inadequate response to two classes of neuropathic pain medications, demonstrating reductions in pain and increased perceived impact of treatment by the patients. 67 …”

Section: Non-pharmacological Treatmentsmentioning

confidence: 99%

Painful Diabetic Peripheral Neuropathy: Practical Guidance and Challenges for Clinical Management

Preston¹,

Riley²,

Azmi³

et al. 2023

DMSO

View full text Add to dashboard Cite

Painful diabetic peripheral neuropathy (PDPN) is present in nearly a quarter of people with diabetes. It is estimated to affect over 100 million people worldwide. PDPN is associated with impaired daily functioning, depression, sleep disturbance, financial instability, and a decreased quality of life. Despite its high prevalence and significant health burden, it remains an underdiagnosed and undertreated condition. PDPN is a complex pain phenomenon with the experience of pain associated with and exacerbated by poor sleep and low mood. A holistic approach to patient-centred care alongside the pharmacological therapy is required to maximise benefit. A key treatment challenge is managing patient expectation, as a good outcome from treatment is defined as a reduction in pain of 30–50%, with a complete pain-free outcome being rare. The future for the treatment of PDPN holds promise, despite a 20-year void in the licensing of new analgesic agents for neuropathic pain. There are over 50 new molecular entities reaching clinical development and several demonstrating benefit in early-stage clinical trials. We review the current approaches to its diagnosis, the tools, and questionnaires available to clinicians, international guidance on PDPN management, and existing pharmacological and non-pharmacological treatment options. We synthesise evidence and the guidance from the American Association of Clinical Endocrinology, American Academy of Neurology, American Diabetes Association, Diabetes Canada, German Diabetes Association, and the International Diabetes Federation into a practical guide to the treatment of PDPN and highlight the need for future research into mechanistic-based treatments in order to prioritise the development of personalised medicine.

show abstract

Frequency Rhythmic Electrical Modulation System (FREMS) to alleviate painful diabetic peripheral neuropathy: A pilot, randomised controlled trial (The FREMSTOP study)

Cited by 5 publications

References 39 publications

Treatment of Painful Diabetic Neuropathy Using Frequency Rhythmic Electro Magnetic Neural Stimulation (FREMS); Effectiveness in Daily Practice

Treatment of Painful Diabetic Neuropathy Using Frequency Rhythmic Electro Magnetic Neural Stimulation (FREMS); Effectiveness in Daily Practice

The 8-Week Efficacy of Frequency Rhythmic Electrical Modulated System (FREMS) as an Add-on Therapy in the Treatment of Symptomatic Diabetic Peripheral Polyneuropathy

Painful Diabetic Peripheral Neuropathy: Practical Guidance and Challenges for Clinical Management

Contact Info

Product

Resources

About