Frequency Rhythmic Electrical Modulation System (FREMS) to alleviate painful diabetic peripheral neuropathy: A pilot,...

Area of Science:

• Neurology
• Pain Management
• Medical Devices

Background:

• Painful diabetic peripheral neuropathy (PDPN) is a chronic pain condition.
• The role of Frequency Rhythmic Electrical Modulated System (FREMS) in PDPN treatment is not well-established.
• Current PDPN treatments often require multiple medications.

Purpose of the Study:

• To evaluate the effectiveness of FREMS as an adjunct treatment for PDPN.
• To assess changes in pain perception and quality of life in PDPN patients receiving FREMS.
• To determine the potential place of FREMS in the PDPN treatment algorithm.

Main Methods:

• A pilot, open-label, randomized controlled trial was conducted.
• Participants with PDPN inadequately controlled on dual neuropathic pain treatments were recruited.
• Participants were randomized to receive FREMS + usual care or usual care alone for 12 weeks.

Main Results:

• FREMS showed a trend towards improved perceived pain compared to controls, though not statistically significant (p=0.087).
• Significant improvements were observed in pain assessed by the McGill Pain questionnaire (p=0.042) and Douleur neuropathique-4 (p=0.042).
• More participants receiving FREMS achieved >30% pain reduction (54% vs 0%, p=0.042) and reported better Patient Global Impression of Change (p=0.005).

Conclusions:

• FREMS may be a viable treatment option for PDPN patients with inadequate pain control on existing therapies.
• FREMS is associated with improvements in pain severity and perceived treatment impact.
• Further large-scale trials are necessary to confirm these findings and establish FREMS's role in PDPN management.