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

  • STATUS
    Recruiting
  • days left to enroll
    27
  • participants needed
    42
  • sponsor
    University of Las Palmas de Gran Canaria
Updated on 4 October 2022

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.

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

Details
Condition Type I Complex Regional Pain Syndrome
Treatment Non-invasive Neuromodulation
Clinical Study IdentifierNCT05052736
SponsorUniversity of Las Palmas de Gran Canaria
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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