CRPS (Complex Regional Pain Syndrome) Type I Clinical Trial
— BLOCALGOOfficial 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
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | February 2024 |
| Est. primary completion date | February 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Pôle Saint Hélier | Rennes | Bretagne |
| Lead Sponsor | Collaborator |
|---|---|
| Pôle Saint Hélier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | hand joint assessment | For an upper limb block :
Kapandji Index at each visit (between 0 to 10) |
1 year | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Assessment of activity limitation for a block of the upper limb | DASH scale at each visit | 1 year | |
| Secondary | Assessment of activity limitation for a block of the lower limb | WOMAC score at each visit | 1 year | |
| Secondary | Assessment of functional capacity | TDM6 at each visit (number of metres travelled by the patient during 6 minutes) | 1 year | |
| Secondary | Assessment of the restriction of participation in social life | Return to work | 1 year | |
| Secondary | Evaluation of the effective dose | - Recording of effective doses (continuous and bolus) | During the CPNB | |
| Secondary | Evaluation of the tolerance of CPNB | - Incident reporting | During the CPNB |