Clinical trial NCT04767646: 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
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CRPS (Complex Regional Pain Syndrome) Type I
Lead sponsor: Pôle Saint Hélier
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: The composite score (the summation of the 3 Goal Attainment Scaling (GAS) scores)
timeFrame: 1 year
Secondary outcomes:
measure: Pain assessment
timeFrame: 1 year
measure: Anxiety assessment
timeFrame: 1 year
measure: Arthrometry assessment
timeFrame: 1 year
measure: hand joint assessment
timeFrame: 1 year
measure: gripping force assessment
timeFrame: 1 year
measure: activity assessment
timeFrame: 1 year
measure: manual dexterity test
timeFrame: 1 year
measure: Assessment of activity limitation for a block of the upper limb
timeFrame: 1 year
measure: Assessment of activity limitation for a block of the lower limb
timeFrame: 1 year
measure: Assessment of functional capacity
timeFrame: 1 year
measure: Assessment of the restriction of participation in social life
timeFrame: 1 year
measure: Evaluation of the effective dose
timeFrame: During the CPNB
measure: Evaluation of the tolerance of CPNB
timeFrame: During the CPNB
Other outcomes:
Locations:
city: Rennes
country: France
facility: Pôle Saint Hélier
state: Bretagne
Study officials:
affiliation: Pôle Saint Hélier
name: Philippe Gallien, Doctor
role: PRINCIPAL_INVESTIGATOR
References: