An interventional study of Non-invasive Neuromodulation in Type I Complex Regional Pain Syndrome, sponsored by University of Las Palmas de Gran Canaria. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by University of Las Palmas de Gran Canaria · Not applicable, Interventional, and Treatment
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.
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
Exclusion Criteria:
Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.
Device: Non-invasive Neuromodulation
Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7.
Device: 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.
Pain ( VAS)
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".
Time frame: Up to 6 month
Quick Dash Test
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
Time frame: Up to 6 month
Muscle balance
The Daniels scale or Daniels test is a tool used to measure the strength of muscles in the human body, especially in patients with neuromuscular disorders or localized injuries. the scale itself follows a specific numbering, with six well-differentiated levels from 0 to 5. These are the following: 0: the muscle does not contract, complete paralysis. 1. the muscle contracts, but there is no movement. The contraction can be palpated or visualized, but there is no movement. 2. the muscle contracts and performs all the movement, but without resistance, since it cannot overcome gravity. 3. the muscle can carry out the movement against gravity as the only resistance. 4. the muscle contracts and performs the full movement, in full range, against gravity and against moderate manual resistance. 5. the muscle contracts and performs the movement in full range against gravity and with maximum manual resistance
Time frame: Up to 6 month
Sleep quality
The Medical Outcomes Study Sleep Scale questionnaire will be used. This instrument was designed to obtain subjective information on the quality and quantity of sleep in the last 4 weeks. It is composed of 12 Likert-type items with 6 degrees of response (from 1-always to 6-never) and grouped into the following categories: * Sleep disturbances * snoring * Waking up with shortness of breath or headache * Amount of sleep * Adequacy of sleep * Daytime sleepiness For its interpretation, a gross estimate of the amount of sleep is obtained (item 2) and scores in the different subscales. The direct scores are transformed into a scale from 0 to 100, with no cut-off points; the higher the score, the greater the intensity of the concept evaluated.
Time frame: Up to 6 month
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University of Las Palmas de Gran Canaria