Non-invasive treatment for Type I Complex Regional Pain Syndrome
Effectiveness and Safety of NXsignal Applied Surface Neurostimulation Technology for the Treatment of Type I Complex Regional Pain Syndrome (CRPS I)
This study is testing a new non-invasive treatment combined with regular care to see if it can help people with Type I Complex Regional Pain Syndrome feel less pain and improve their daily activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Las Palmas de Gran Canaria Academic / other |
| Locations | 1 site (Las Palmas de Gran Canaria, Palmas, Las) |
| Trial ID | NCT05052736 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of non-invasive neuromodulation combined with conventional care for patients suffering from Type I Complex Regional Pain Syndrome (CRPS). It is a randomized, triple-blind clinical trial involving 42 participants who will be divided into control and experimental groups. The study aims to assess pain relief and functional improvement at three different time points: before, during, and after the intervention. Statistical analyses will be conducted to evaluate the outcomes and determine the significance of the findings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who meet the Budapest criteria for CRPS type I and are within 0 to 6 months of symptom onset.
Not a fit: Patients with CRPS type II, those with multiple affected limbs, or individuals who have had a recurrence of CRPS type I may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improved function for patients with Type I CRPS.
How similar studies have performed: While there is ongoing research in neuromodulation for pain management, this specific approach for Type I CRPS is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Las Palmas de Gran Canaria, Palmas, Las
- Aníbal Báez Suárez — Las Palmas de Gran Canaria, Palmas, Las, Spain (Recruiting)
Study contacts
- Principal investigator: Aníbal Báez-Suárez, PhD — University of Las Palmas de Gran Canaria
- Study coordinator: Aníbal Báez-Suárez, PhD
- Email: anibal.baez@ulpgc.es
- Phone: +34 652077692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.