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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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CRPS (Complex Regional Pain Syndrome) Type I

Intervention / Treatment
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* Procedure: Intensive rehabilitation program with CPNB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-BNP with intensive rehabilitation program<br> | Procedure: Intensive rehabilitation program with CPNB<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment | EVA (Visual Analogue Scale, VAS) for all the patients at each visit This is a measure of pain intensity on a scale of 0 (no pain) to 10 (very severe pain). We will assess the percentage of pain relief with the EVA scale, before and after the PCNB. | 1 year | 
| Anxiety assessment | Hospital Anxiety and Depression (HAD) scale for all the patients at each visit There will be 2 scores One to assess anxiety : from 0 to 21 and one to assess depression : from 0 to 21 Higher scores mean a worse outcome. | 1 year | 
| Arthrometry assessment | For an upper limb block : Passive and active arthrometry (angular measurements for shoulder, elbow and wrist) For a block of the lower limb : Passive and active arthrometry (angular measurements for hip, knee and ankle) | 1 year | 
| hand joint assessment | For an upper limb block : Kapandji Index at each visit (between 0 to 10) | 1 year | 
| gripping force assessment | For an upper limb block, gripping force will be evaluated with a Jamar and Pinch dynamometer at each visit after BNPc | 1 year | 
| activity assessment | For an upper limb block, the activity limitation will be evaluated by leroux's scapular index (LSI) with a global score out of 100 at each visit after BNPc | 1 year | 
| manual dexterity test | For an upper limb block, the dexterity will be evaluated by a Box and Block Test at each visit after BNPc | 1 year | 
| Assessment of activity limitation for a block of the upper limb | DASH scale at each visit | 1 year | 
| Assessment of activity limitation for a block of the lower limb | WOMAC score at each visit | 1 year | 
| Assessment of functional capacity | TDM6 at each visit (number of metres travelled by the patient during 6 minutes) | 1 year | 
| Assessment of the restriction of participation in social life | Return to work | 1 year | 
| Evaluation of the effective dose | - Recording of effective doses (continuous and bolus) | During the CPNB | 
| Evaluation of the tolerance of CPNB | - Incident reporting | During the CPNB |