Non Invasive Neurostimulation Technology for the Treatment of Type I Complex Regional Pain Syndrome (CRPS I)
NCT ID: NCT05052736
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
42 participants
INTERVENTIONAL
2022-03-28
2026-12-27
Brief Summary
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The purpose of this study is to investigate the effect on complex pain syndrome using a conventional care protocol plus the application of non-invasive neuromodulation during compared to the effect of the same protocol plus placebo.
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Detailed Description
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The size of the sample will be 42 participants who come to referral hospitals. They will be randomized in two groups: control or experimental.
The variables of the study will be collected at three time points: before the intervention, during the intervention and at the end of the intervention.
The variables of the study will be collected at two time points: before the intervention and at the end of the intervention.
The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with kruskal wallis correction correction. Statistical significance will be defined as p \<0.05
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Non-invasive Neuromodulation
Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.
Non-invasive Neuromodulation
The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 20 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7.
Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 millivolt and intensity 0.5 μA.
Placebo Non-invasive Neuromodulation
Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7.
Non-invasive Neuromodulation
The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 20 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7.
Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 millivolt and intensity 0.5 μA.
Interventions
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Non-invasive Neuromodulation
The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 20 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7.
Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 millivolt and intensity 0.5 μA.
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 65.
* Period between 0 and 6 months after the onset of the clinical picture.
* Have signed the informed consent of their own free will.
Exclusion Criteria
* Present type I CRPS in more than one limb.
* Patients who have suffered a recurrence of CRPS type I.
* Pregnancy or plans for it during the study.
* Previous sympathectomy in the affected limb.
18 Years
ALL
No
Sponsors
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University of Las Palmas de Gran Canaria
OTHER
Responsible Party
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Aníbal Báez Suárez
Principal Investigator
Principal Investigators
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Aníbal Báez-Suárez, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Las Palmas de Gran Canaria
Locations
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Aníbal Báez Suárez
Las Palmas de Gran Canaria, Palmas, Las, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Sebastin SJ. Complex regional pain syndrome. Indian J Plast Surg. 2011 May;44(2):298-307. doi: 10.4103/0970-0358.85351.
Wasner G, Schattschneider J, Binder A, Baron R. Complex regional pain syndrome--diagnostic, mechanisms, CNS involvement and therapy. Spinal Cord. 2003 Feb;41(2):61-75. doi: 10.1038/sj.sc.3101404.
Todorova J, Dantchev N, Petrova G. Complex regional pain syndrome acceptance and the alternative denominations in the medical literature. Med Princ Pract. 2013;22(3):295-300. doi: 10.1159/000343905. Epub 2012 Nov 16.
Bruehl S. An update on the pathophysiology of complex regional pain syndrome. Anesthesiology. 2010 Sep;113(3):713-25. doi: 10.1097/ALN.0b013e3181e3db38.
Ratti C, Nordio A, Resmini G, Murena L. Post-traumatic complex regional pain syndrome: clinical features and epidemiology. Clin Cases Miner Bone Metab. 2015 Jan-Apr;12(Suppl 1):11-6. doi: 10.11138/ccmbm/2015.12.3s.011. Epub 2016 Apr 7.
Sandroni P, Benrud-Larson LM, McClelland RL, Low PA. Complex regional pain syndrome type I: incidence and prevalence in Olmsted county, a population-based study. Pain. 2003 May;103(1-2):199-207. doi: 10.1016/s0304-3959(03)00065-4.
Elsamadicy AA, Yang S, Sergesketter AR, Ashraf B, Charalambous L, Kemeny H, Ejikeme T, Ren X, Pagadala P, Parente B, Xie J, Lad SP. Prevalence and Cost Analysis of Complex Regional Pain Syndrome (CRPS): A Role for Neuromodulation. Neuromodulation. 2018 Jul;21(5):423-430. doi: 10.1111/ner.12691. Epub 2017 Sep 29.
Albazaz R, Wong YT, Homer-Vanniasinkam S. Complex regional pain syndrome: a review. Ann Vasc Surg. 2008 Mar;22(2):297-306. doi: 10.1016/j.avsg.2007.10.006.
Other Identifiers
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NESAMAZ
Identifier Type: -
Identifier Source: org_study_id
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