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Electrical stimulation with EVNS (Electrical Vasomotor Neuro Stimulation), a methodology used by a specific group of neurostimulators known under various names, has proven its benefit in Painful Diabetic Neuropathy (PDN). However, due to the impaired mobility from Diabetic Neuropathy, a part of subjects did not finish the 10 days treatment in the outpatient clinic. Another part of the target group decided not to participate at all for the same reason.
The current study investigates the feasibility, safety and performance of a newly developed EVNS device, called Releaf™, optimised for HOME treatment,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVNS treatment | Experimental | EVNS, see intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Releaf | Device | 10 days/35 minutes per day EVNS (non-invasive electrostimulation) treatment on lower legs and feet by the subject or its caregiver after instruction by the podiatrist. |
| Measure | Description | Time Frame |
|---|---|---|
| Side-effects | The number and severity of reported side-effects of HOME-EVNS, gathered via telephonic consulting on treatment day 1,3 and 8 and via user-initiated incoming calls to the PI | Day 1-10 |
| Successful treatment cycles | The successful treatment cycles applied at home, defined as cycles with at least 8/10 successful (full 35 minutes) treatment sessions, derived from the adherence determined by recording device usage and intensity setting which is downloaded from device after its retrieval | Day 11 |
| Reported usability | Usability by the User Questionnaire | Day 10 |
| Use of helpdesk | The number of help requests to service desk. | Day 1-10 |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathic pain | Neuropathic Pain Symptom Inventory (NPSI) filled in by subject | Before start, after 1 month, after 3 months |
| Quality of life score | EuroQol 5 Dimension 5 Level (EQ-5D-5L) QoL filled in by subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ben Imholz, PhD, MD | Neurecon BV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurecon | Vught | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26008721 | Background | Alleman CJ, Westerhout KY, Hensen M, Chambers C, Stoker M, Long S, van Nooten FE. Humanistic and economic burden of painful diabetic peripheral neuropathy in Europe: A review of the literature. Diabetes Res Clin Pract. 2015 Aug;109(2):215-25. doi: 10.1016/j.diabres.2015.04.031. Epub 2015 May 6. | |
| 30828432 | Background |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| Before start, after 1 month, after 3 months |
| Azmi S, Petropoulos IN, Ferdousi M, Ponirakis G, Alam U, Malik RA. An update on the diagnosis and treatment of diabetic somatic and autonomic neuropathy. F1000Res. 2019 Feb 15;8:F1000 Faculty Rev-186. doi: 10.12688/f1000research.17118.1. eCollection 2019. |
| 18250616 | Background | Bevilacqua M, Dominguez LJ, Barrella M, Barbagallo M. Induction of vascular endothelial growth factor release by transcutaneous frequency modulated neural stimulation in diabetic polyneuropathy. J Endocrinol Invest. 2007 Dec;30(11):944-7. doi: 10.1007/BF03349242. |
| 20207576 | Background | Bocchi L, Evangelisti A, Barrella M, Scatizzi L, Bevilacqua M. Recovery of 0.1Hz microvascular skin blood flow in dysautonomic diabetic (type 2) neuropathy by using Frequency Rhythmic Electrical Modulation System (FREMS). Med Eng Phys. 2010 May;32(4):407-13. doi: 10.1016/j.medengphy.2010.02.004. Epub 2010 Mar 6. |
| 15834546 | Background | Bosi E, Conti M, Vermigli C, Cazzetta G, Peretti E, Cordoni MC, Galimberti G, Scionti L. Effectiveness of frequency-modulated electromagnetic neural stimulation in the treatment of painful diabetic neuropathy. Diabetologia. 2005 May;48(5):817-23. doi: 10.1007/s00125-005-1734-2. Epub 2005 Apr 15. |
| 23238789 | Background | Bosi E, Bax G, Scionti L, Spallone V, Tesfaye S, Valensi P, Ziegler D; FREMS European Trial Study Group. Frequency-modulated electromagnetic neural stimulation (FREMS) as a treatment for symptomatic diabetic neuropathy: results from a double-blind, randomised, multicentre, long-term, placebo-controlled clinical trial. Diabetologia. 2013 Mar;56(3):467-75. doi: 10.1007/s00125-012-2795-7. Epub 2012 Dec 13. |
| 34605077 | Background | Crasto W, Altaf QA, Selvaraj DR, Jack B, Patel V, Nawaz S, Murthy N, Sukumar N, Saravanan P, Tahrani AA. Frequency Rhythmic Electrical Modulation System (FREMS) to alleviate painful diabetic peripheral neuropathy: A pilot, randomised controlled trial (The FREMSTOP study). Diabet Med. 2022 Mar;39(3):e14710. doi: 10.1111/dme.14710. Epub 2021 Nov 3. |
| 35716275 | Background | D'Souza RS, Barman R, Joseph A, Abd-Elsayed A. Evidence-Based Treatment of Painful Diabetic Neuropathy: a Systematic Review. Curr Pain Headache Rep. 2022 Aug;26(8):583-594. doi: 10.1007/s11916-022-01061-7. Epub 2022 Jun 18. |
| 19356853 | Background | Dworkin RH, Turk DC, Revicki DA, Harding G, Coyne KS, Peirce-Sandner S, Bhagwat D, Everton D, Burke LB, Cowan P, Farrar JT, Hertz S, Max MB, Rappaport BA, Melzack R. Development and initial validation of an expanded and revised version of the Short-form McGill Pain Questionnaire (SF-MPQ-2). Pain. 2009 Jul;144(1-2):35-42. doi: 10.1016/j.pain.2009.02.007. Epub 2009 Apr 7. |
| 11123230 | Background | Emerson GG, Segal SS. Electrical activation of endothelium evokes vasodilation and hyperpolarization along hamster feed arteries. Am J Physiol Heart Circ Physiol. 2001 Jan;280(1):H160-7. doi: 10.1152/ajpheart.2001.280.1.H160. |
| 30941745 | Background | Gibson W, Wand BM, Meads C, Catley MJ, O'Connell NE. Transcutaneous electrical nerve stimulation (TENS) for chronic pain - an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2019 Apr 3;4(4):CD011890. doi: 10.1002/14651858.CD011890.pub3. |
| 36612433 | Background | Gorczyca-Siudak D, Dziemidok P. The 8-Week Efficacy of Frequency Rhythmic Electrical Modulated System (FREMS) as an Add-on Therapy in the Treatment of Symptomatic Diabetic Peripheral Polyneuropathy. Int J Environ Res Public Health. 2022 Dec 22;20(1):111. doi: 10.3390/ijerph20010111. |
| 32539841 | Background | Gunter C, Delbeke J, Ortiz-Catalan M. Correction to: Safety of long-term electrical peripheral nerve stimulation: review of the state of the art. J Neuroeng Rehabil. 2020 Jun 15;17(1):77. doi: 10.1186/s12984-020-00695-1. |
| 37197061 | Background | Imholz B, Heijster J, Tahrani A, Kooy A. Treatment of Painful Diabetic Neuropathy Using Frequency Rhythmic Electro Magnetic Neural Stimulation (FREMS); Effectiveness in Daily Practice. Diabetes Metab Syndr Obes. 2023 May 11;16:1383-1391. doi: 10.2147/DMSO.S401727. eCollection 2023. |
| 35144946 | Background | Johnson MI, Paley CA, Jones G, Mulvey MR, Wittkopf PG. Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study). BMJ Open. 2022 Feb 10;12(2):e051073. doi: 10.1136/bmjopen-2021-051073. |
| 30793414 | Background | Perrot S, Lanteri-Minet M. Patients' Global Impression of Change in the management of peripheral neuropathic pain: Clinical relevance and correlations in daily practice. Eur J Pain. 2019 Jul;23(6):1117-1128. doi: 10.1002/ejp.1378. Epub 2019 Mar 18. |
| 34842478 | Background | Strand NH, Burkey AR. Neuromodulation in the Treatment of Painful Diabetic Neuropathy: A Review of Evidence for Spinal Cord Stimulation. J Diabetes Sci Technol. 2022 Mar;16(2):332-340. doi: 10.1177/19322968211060075. Epub 2021 Nov 29. |
| 23732189 | Background | Tesfaye S, Wilhelm S, Lledo A, Schacht A, Tolle T, Bouhassira D, Cruccu G, Skljarevski V, Freynhagen R. Duloxetine and pregabalin: high-dose monotherapy or their combination? The "COMBO-DN study"--a multinational, randomized, double-blind, parallel-group study in patients with diabetic peripheral neuropathic pain. Pain. 2013 Dec;154(12):2616-2625. doi: 10.1016/j.pain.2013.05.043. Epub 2013 May 31. |
| 36375183 | Background | Wang EJ, Berninger LE, Komargodski O, Smith TJ. Painful Diabetic Neuropathy - Spinal Cord Stimulation, Peripheral Nerve Stimulation, Transcutaneous Electrical Nerve Stimulation, and Scrambler Therapy: A Narrative Review. Pain Physician. 2022 Nov;25(8):E1163-E1173. |
| 33154432 | Background | Zeng H, Pacheco-Barrios K, Cao Y, Li Y, Zhang J, Yang C, Fregni F. Non-invasive neuromodulation effects on painful diabetic peripheral neuropathy: a systematic review and meta-analysis. Sci Rep. 2020 Nov 5;10(1):19184. doi: 10.1038/s41598-020-75922-9. |
| 14679307 | Background | Zhao M, Bai H, Wang E, Forrester JV, McCaig CD. Electrical stimulation directly induces pre-angiogenic responses in vascular endothelial cells by signaling through VEGF receptors. J Cell Sci. 2004 Jan 26;117(Pt 3):397-405. doi: 10.1242/jcs.00868. Epub 2003 Dec 16. |
| 34547367 | Background | Ziegler D, Tesfaye S, Spallone V, Gurieva I, Al Kaabi J, Mankovsky B, Martinka E, Radulian G, Nguyen KT, Stirban AO, Tankova T, Varkonyi T, Freeman R, Kempler P, Boulton AJ. Screening, diagnosis and management of diabetic sensorimotor polyneuropathy in clinical practice: International expert consensus recommendations. Diabetes Res Clin Pract. 2022 Apr;186:109063. doi: 10.1016/j.diabres.2021.109063. Epub 2021 Sep 20. |
| 36318674 | Background | Zucatti KP, Teixeira PP, Wayerbacher LF, Piccoli GF, Correia PE, Fonseca NKO, Moresco KS, Guerra BA, Madure MG, Farenzena LP, Frankenberg AD, Brietzke E, Halpern B, Franco O, Colpani V, Gerchman F. Long-term Effect of Lifestyle Interventions on the Cardiovascular and All-Cause Mortality of Subjects With Prediabetes and Type 2 Diabetes: A Systematic Review and Meta-analysis. Diabetes Care. 2022 Nov 1;45(11):2787-2795. doi: 10.2337/dc22-0642. |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |