Non-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.
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Pain ( VAS) — Up to 6 month The instrument will be used to measure the change of pain before and after the intervention will be the Visual Analogue Scale (VAS).
Participants will be asked to mark the level of their pain on a 100 mm, no hatched VAS scale marked at one end as "no pain" and at the other as "worst pain imaginable".
Quick Dash Test — Up to 6 month The Quick DASH Upper Extremity Rating Scale for Upper Extremity can be completed by the patient in aid of the orthopedic surgeon. It consists of 11 items that assess the presence of symptoms and the functional capacity of the individual surveyed during the last week. A total of 11 questions must be answered for the questionnaire to calculate the functional situation accurately
Trial sites (1)
Facility
City
Region
Status
Aníbal Báez Suárez
Las Palmas de Gran Canaria
Palmas, Las
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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