FREMSTOP study. (version 1.0)
Research type
Research Study
Full title
Frequency rhythmic electrical modulation system (FREMS) to alleviate painful diabetic peripheral neuropathy: a pilot randomised controlled trial (The FREMSTOP study).
IRAS ID
243899
Contact name
Winston Crasto
Contact email
Sponsor organisation
George Eliot Hospital NHS Trust
Duration of Study in the UK
1 years, 1 months, 29 days
Research summary
Diabetic peripheral neuropathy (DPN) is a microvascular complication which occurs in a third of patients with diabetes. Common symptoms which occur predominantly in the lower limbs include pain and numbness resulting in significant disability, sleep disturbances and negative effects on quality of life.
Current UK management guidelines suggests anti-neuropathic drugs as first line treatment. However, there is uncertainty in finding the best drug or combination therapy to alleviate symptoms and pharmacotherapy often provides limited benefit with unacceptable side effects.
Frequency rhythmic electrical modulation system (FREMS) delivered by the Aptiva device, is a novel, non-drug approach to alleviate neuropathic pain. Electric pulses with sequentially modulated frequencies are delivered via electrode pads applied to the lower extremities. Each daily treatment session lasts approximately 35 minutes and a whole treatment cycle requires 10 sessions (10 days) over 2 weeks. Research studies with FREMS have shown short-term (lasting upto 12 week) benefits, with improvements in quality of life. Its efficacy as 'add-on' agent to dual or second-line anti-neuropathic agents thereby avoiding need for escalating drug combinations has not been studied.
The primary objective of this pilot, single centre, active-comparator, open label, pragmatic, randomized controlled trial is to assess efficacy of a single FREMS treatment cycle in individuals not controlled atleast with second-line anti-neuropathic agents. Secondary objectives are to assess impact of a single FREMS treatment cycle on quality of life, acceptability of therapy, improvement in sleep and consumption of medications.
70 individuals aged between 18-75 years, with a pain score >4 on the Pain visual analog scale, will be recruited from GP practices/hospital clinics across Warwickshire, UK. Intensive group participants will be randomized to FREMS therapy whereas control group will receive standard care by own health care professional. Duration of the trial from recruitment to study end is planned over 14 months.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0283
Date of REC Opinion
5 Sep 2018
REC opinion
Favourable Opinion