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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Aníbal Báez Suárez
RECRUITING
Las Palmas De Gran Canaria
Contact Information
Primary
Aníbal Báez-Suárez, PhD
anibal.baez@ulpgc.es
+34 652077692
Backup
Aníbal Báez-Suárez, PhD
anibal.baez@ulpgc.es
+34652077692
Time Frame
Start Date: 2022-03-28
Estimated Completion Date: 2026-12-27
Participants
Target number of participants: 42
Treatments
Experimental: Non-invasive Neuromodulation
Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.
Placebo_comparator: Placebo Non-invasive Neuromodulation
Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7.
Related Therapeutic Areas
Sponsors
Leads: University of Las Palmas de Gran Canaria

This content was sourced from clinicaltrials.gov