Clinical trial NCT05052736: Non Invasive Neurostimulation Technology for the Treatment of Type I Complex Regional Pain Syndrome (CRPS I)
Official title: Effectiveness and Safety of NXsignal Applied Surface Neurostimulation Technology for the Treatment of Type I Complex Regional Pain Syndrome (CRPS I)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type I Complex Regional Pain Syndrome
Keywords: physical therapy modality
Electric Stimulation Therapy
pain
Lead sponsor: University of Las Palmas de Gran Canaria
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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 outcomes:
measure: Pain ( VAS)
timeFrame: Up to 6 month
measure: Quick Dash Test
timeFrame: Up to 6 month
Secondary outcomes:
measure: Muscle balance
timeFrame: Up to 6 month
measure: Sleep quality
timeFrame: Up to 6 month
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Aníbal Báez Suárez
state: Palmas, Las
Study officials:
affiliation: University of Las Palmas de Gran Canaria
name: Aníbal Báez-Suárez, PhD
role: PRINCIPAL_INVESTIGATOR
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