NCT04767646CompletedNot Applicable
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
Pôle Saint Hélier2 sites in 1 country30 target enrollmentStarted: February 23, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- The composite score (the summation of the 3 Goal Attainment Scaling (GAS) scores)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
C-BNP with intensive rehabilitation program
Experimental
Intervention: Intensive rehabilitation program with CPNB (Procedure)
Outcomes
Primary Outcomes
The composite score (the summation of the 3 Goal Attainment Scaling (GAS) scores)
Time Frame: 1 year
The improvement of the composite score following BNPc combined with intensive rehabilitation.
Secondary Outcomes
- Arthrometry assessment(1 year)
- hand joint assessment(1 year)
- activity assessment(1 year)
- Pain assessment(1 year)
- gripping force assessment(1 year)
- manual dexterity test(1 year)
- Assessment of functional capacity(1 year)
- Anxiety assessment(1 year)
- Assessment of activity limitation for a block of the upper limb(1 year)
- Assessment of activity limitation for a block of the lower limb(1 year)
- Assessment of the restriction of participation in social life(1 year)
- Evaluation of the effective dose(During the CPNB)
- Evaluation of the tolerance of CPNB(During the CPNB)
Investigators
Study Sites (2)
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