Using Burst Mode Spinal Cord Stimulation for Upper Limb Pain Relief
Observational, Prospective, Monocentric Study Aimed at Studying the Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs Evaluation Protocol by Quantitative and Qualitative Method
This study is testing a new way of using spinal cord stimulation to see if it can help people with upper limb pain from Complex Regional Pain Syndrome feel better with fewer side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Elsan Academic / other |
| Locations | 1 site (Nantes) |
| Trial ID | NCT05877612 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Burst mode spinal cord stimulation in treating Complex Regional Pain Syndrome Type I in the upper limbs. It focuses on the experiences of patients and the outcomes of this innovative stimulation technique, which aims to reduce side effects associated with traditional spinal cord stimulation. The Burst mode is designed to activate specific pain pathways, potentially leading to improved pain management and patient comfort over time. The study will involve patients who meet specific eligibility criteria and can be followed for at least one year.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with Complex Regional Pain Syndrome affecting at least one upper limb.
Not a fit: Patients with uncontrolled infections, those who are pregnant or breastfeeding, or individuals who have previously undergone spinal cord stimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide significant pain relief and improved quality of life for patients suffering from Complex Regional Pain Syndrome.
How similar studies have performed: While the Burst mode is a newer approach, previous studies on spinal cord stimulation have shown promising results, indicating potential for success with this method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients between 18 and 75 years of age * Patient with CRPS of at least one upper limb * Patient affiliated to a Social Security plan * Patient who has signed and dated the no-objection form * Patient with the cognitive ability to understand the treatment and complete the questionnaires * Patient who can be followed for a minimum of 1 year Exclusion Criteria: * Patient with an uncontrolled infection * Pregnant or breastfeeding patient * Patient who has already undergone treatment by spinal cord stimulation * Patient with a contraindication to the percutaneous technique (cervical spine surgery, infection...) * Patient who cannot be followed regularly for psychological, social, family or geographical reasons * Protected participant: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
Where this trial is running
Nantes
- Clinique BRETECHE — Nantes, France (Recruiting)
Study contacts
- Principal investigator: Sylvain DURAND, Dr — Clinique Bretéché ELSAN
- Study coordinator: Vincent WYART, MSc
- Email: vincent.wyart@elsan.care
- Phone: 0240958176
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.