Evaluating the impact of early nerve blocks and rehabilitation on Complex Regional Pain Syndrome Type 1
Evaluation of the Relationship Between the Duration of the Evolution of the Complex Regional Pain Syndrome Type 1 (CRPS 1) and Effectiveness of the Continuous Peripheral Nerve Block (CPNB) Associated With an Intensive Rehabilitation Program
This study is testing if starting nerve blocks earlier, along with a rehab program, can help people with Complex Regional Pain Syndrome Type 1 recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pôle Saint Hélier Academic / other |
| Locations | 1 site (Rennes, Brittany Region) |
| Trial ID | NCT04767646 on ClinicalTrials.gov |
What this trial studies
This study investigates how the duration of Complex Regional Pain Syndrome Type 1 (CRPS 1) affects the effectiveness of continuous peripheral nerve blocks (CPNB) combined with an intensive rehabilitation program. The main hypothesis is that earlier intervention with CPNB will lead to better recovery outcomes, as measured by a scale of achievement of therapeutic objectives. Participants will receive CPNB and engage in a structured rehabilitation program to assess improvements in their condition. The study aims to refine therapeutic strategies for managing CRPS 1.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with CRPS Type 1 who are experiencing severe pain and have not responded to other treatments.
Not a fit: Patients with CRPS Type 2 or those who have contraindications to the analgesics used will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery outcomes for patients suffering from CRPS Type 1.
How similar studies have performed: While there is ongoing research in pain management for CRPS, this specific approach combining CPNB with intensive rehabilitation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * informed consent signed * Diagnosis of CRPS type 1 according to BUDAPEST criteria to the upper or lower limb * Affiliated to a social security scheme (beneficiary or entitled person) * Patients justifying the installation of a Continuous Peripheral Nerve Block (CPNB) including pain rebellious to physical and medicinal treatments, the presence of fixed dystonia, or kinesiphobia or who are no longer progressing in the rehabilitation algorithm and requiring the need for a specialised technical platform. Exclusion Criteria: * CRPS Type 2 * Contra-indication to the analgesics used (bupivacaine, ropivacaine, levobupivacaine) * Severe psychiatric decompensation * Under legal protection measures * Pregnant women
Where this trial is running
Rennes, Brittany Region
- Pôle Saint Hélier — Rennes, Brittany Region, France (Recruiting)
Study contacts
- Principal investigator: Philippe Gallien, Doctor — Pôle Saint Hélier
- Study coordinator: Philippe Gallien, Doctor
- Email: philippe.gallien@pole-sthelier.com
- Phone: 0299295099
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.