Type I Complex Regional Pain Syndrome Clinical Trial
Official title:
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 ;