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

University of Las Palmas de Gran Canaria

Status: Enrolling

Conditions: Type I Complex Regional Pain Syndrome

Treatments: Device: Non-invasive Neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05052736

NESAMAZ

Details and patient eligibility

About

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.

Full 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

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

Non-invasive Neuromodulation

Experimental group

Description:

Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.

Treatment:

Device: Non-invasive Neuromodulation

Placebo Non-invasive Neuromodulation

Placebo Comparator group

Description:

Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7.

Treatment:

Device: Non-invasive Neuromodulation