Non Invasive Neurostimulation Technology for the Treatment of Type I Complex Regional Pain Syndrome (CRPS I)

Last updated: November 1, 2024
Sponsor: University of Las Palmas de Gran Canaria
Overall Status: Active - Recruiting

Phase

N/A

Condition

Reflex Sympathetic Dystrophy Syndrome (Rsds)

Somatoform And Dissociative Disorders

Mood Disorders

Treatment

Non-invasive Neuromodulation

Clinical Study ID

NCT05052736
NESAMAZ
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet the Budapest criteria for the clinical diagnosis of CRPS type I.

  • 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

Exclusion Criteria:

  • Have a diagnosis of CRPS type II.

  • 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.

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: Non-invasive Neuromodulation
Phase:
Study Start date:
March 28, 2022
Estimated Completion Date:
December 27, 2025

Study Description

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

Connect with a study center

  • Aníbal Báez Suárez

    Las Palmas De Gran Canaria, Palmas, Las 35016
    Spain

    Active - Recruiting

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