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
BLOCALGO
1 other identifier
interventional
30
1 country
1
Brief Summary
The study evaluates the relationship between the duration of evolution of SDRC1 and the efficacy of continuous peripheral nerve block (c-PNB) associated with an intensive rehabilitation program to improve the therapeutic strategy of SDRC1. The main hypothesis of this study is that if c-PNB is proposed earlier, the recovery, measured with a scale achievement of objectives, will be better.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2021
CompletedFirst Posted
Study publicly available on registry
February 23, 2021
CompletedStudy Start
First participant enrolled
February 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedApril 9, 2025
April 1, 2025
4.9 years
February 5, 2021
April 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The composite score (the summation of the 3 Goal Attainment Scaling (GAS) scores)
The improvement of the composite score following BNPc combined with intensive rehabilitation.
1 year
Secondary Outcomes (13)
Pain assessment
1 year
Anxiety assessment
1 year
Arthrometry assessment
1 year
hand joint assessment
1 year
gripping force assessment
1 year
- +8 more secondary outcomes
Study Arms (1)
C-BNP with intensive rehabilitation program
EXPERIMENTALInterventions
The patient will have an intensive rehabilitation program (two 30-minute kinesitherapy sessions every day and 30-minute occupational therapy sessions 5 days a week) with the CPNB. The patient will have follow-up consultation at 1 month, 3 month, 6 month and 1 year after the beggining of the intensive rehabilitation program
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- CRPS Type 2
- Contra-indication to the analgesics used (bupivacaine, ropivacaine, levobupivacaine)
- Severe psychiatric decompensation
- Under legal protection measures
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pôle Saint Hélier
Rennes, Brittany Region, 35000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe Gallien, Doctor
Pôle Saint Hélier
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2021
First Posted
February 23, 2021
Study Start
February 23, 2021
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
April 9, 2025
Record last verified: 2025-04