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Frequency rhythmic electrical modulation system (FREMS) to alleviate painful diabetic peripheral neuropathy : a pilot, randomised controlled trial (The FREMSTOP study)
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Crasto, W., Altaf, Q -A., Selvaraj, D. R., Jack, B., Patel, Vinod, Nawaz, S., Murthy, N., Sukumar, Nithya, Saravanan, Ponnusamy and Tahrani, A. A. (2022) Frequency rhythmic electrical modulation system (FREMS) to alleviate painful diabetic peripheral neuropathy : a pilot, randomised controlled trial (The FREMSTOP study). Diabetic medicine : a journal of the British Diabetic Association, 39 (3). e14710. doi:10.1111/dme.14710
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Official URL: http://dx.doi.org/10.1111/dme.14710
Abstract
Frequency Rhythmic Electrical Modulated system (FREMS) is a non-invasive treatment for chronic pain conditions but its place in the treatment algorithm for painful diabetic peripheral neuropathy (PDPN) is unknown. A pilot, open-label randomised controlled trial in individuals with PDPN inadequately controlled on at least dual neuropathic pain treatments recruited from primary and secondary care. Participants were randomised 1:1 to FREMS+usual care(n=13) vs. usual care(n=12). Primary outcome was change from baseline in perceived pain (assessed by visual analogue scale) at 12 weeks between treatment groups. Of 25 participants, 14(56%) were men and 21(84%) were White Europeans. Median(IQR) age and duration of diabetes were 64(56,68) and 14(10,20) years, respectively. At 12 weeks, FREMS showed improvements in perceived pain compared to baseline, although the change was not statistically significant from control group [-4.0(-5.0,0.4) vs 0(-0.3,0.7), p=0.087]. There were significant improvements in pain with FREMS, assessed by McGill Pain questionnaire (p=0.042) and Douleur neuropathique-4 questionnaire (p=0.042). More patients on FREMS had greater than 30 percent reductions in perceived pain compared to controls [7/13(54%) vs. 0/12(0%), p=0.042] and significant improvements in Patient Global Impression of Change (p=0.005). FREMS intervention had moderate benefits in quality of life, sleep, depression and pain medication use, but these were not statistically significant. FREMS might be used to treat individuals with PDPN inadequately controlled on two classes of neuropathic pain medications and is associated with improvements in pain severity and perceived impact of treatment. A larger, appropriately designed trial assessing its impact in this population is needed. [Abstract copyright: This article is protected by copyright. All rights reserved.]
| Item Type: | Journal Article | ||||||||
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Population, Evidence & Technologies (PET) Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| SWORD Depositor: | Library Publications Router | ||||||||
| Journal or Publication Title: | Diabetic medicine : a journal of the British Diabetic Association | ||||||||
| Publisher: | Wiley-Blackwell Publishing Ltd. | ||||||||
| ISSN: | 0742-3071 | ||||||||
| Official Date: | March 2022 | ||||||||
| Dates: |
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| Volume: | 39 | ||||||||
| Number: | 3 | ||||||||
| Article Number: | e14710 | ||||||||
| DOI: | 10.1111/dme.14710 | ||||||||
| Status: | Peer Reviewed | ||||||||
| Publication Status: | Published | ||||||||
| Publisher Statement: | "This is the peer reviewed version of the following article: [FULL CITE], which has been published in final form at [Link to final article using the DOI]. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. This article may not be enhanced, enriched or otherwise transformed into a derivative work, without express permission from Wiley or by statutory rights under applicable legislation. Copyright notices must not be removed, obscured or modified. The article must be linked to Wiley’s version of record on Wiley Online Library and any embedding, framing or otherwise making available the article or pages thereof by third parties from platforms, services and websites other than Wiley Online Library must be prohibited." | ||||||||
| Access rights to Published version: | Restricted or Subscription Access | ||||||||
| Copyright Holders: | © 2021 Diabetes UK |
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