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Effectiveness and Safety of NXsignal Applied Surface Neurostimulation Technology for the Treatment of Type I Complex Regional Pain Syndrome (CRPS I)
Complex Regional Pain Syndrome (CRPS) / Complex Regional Pain Syndrome (CRPS) is a chronic neurological disorder that affects the extremities and is characterized by disabling pain, swelling, vasomotor instability, sudomotor abnormality, and impaired motor function; the duration and clinical magnitude is greater than expected, being divided into three stages of progression over time: Stage I: acute (0-3 months); Stage II: dystrophic (3-9 months); Stage 3: atrophic (9-18 months). 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.
The design of this study is a randomised, triple blind clinical trial with placebo control. 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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Aníbal Báez Suárez
Las Palmas de Gran Canaria, Palmas, Las, Spain
Start Date
March 28, 2022
Primary Completion Date
April 27, 2026
Completion Date
December 27, 2026
Last Updated
August 28, 2025
42
ESTIMATED participants
Non-invasive Neuromodulation
DEVICE
Lead Sponsor
University of Las Palmas de Gran Canaria
Data Source & Attribution
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