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RecruitingNot ApplicableNCT05052736

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

Effectiveness and Safety of NXsignal Applied Surface Neurostimulation Technology for the Treatment of Type I Complex Regional Pain Syndrome (CRPS I)

Sponsor

University of Las Palmas de Gran Canaria

Enrollment

42 participants

Start Date

Mar 28, 2022

Study Type

INTERVENTIONAL

Conditions

Type I Complex Regional Pain Syndrome

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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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Interventions

DEVICENon-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.

Locations(1)

Aníbal Báez Suárez

Las Palmas de Gran Canaria, Palmas, Las, Spain

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NCT05052736