Back to resultsEvaluation 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)
Primary Purpose
CRPS (Complex Regional Pain Syndrome) Type I
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intensive rehabilitation program with CPNB
Sponsored by
About this trial
This is an interventional supportive care trial for CRPS (Complex Regional Pain Syndrome) Type I
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
Sites / Locations
- Pôle Saint HélierRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
C-BNP with intensive rehabilitation program
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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)
hand joint assessment
For an upper limb block :
Kapandji Index at each visit (between 0 to 10)
gripping force assessment
For an upper limb block, gripping force will be evaluated with a Jamar and Pinch dynamometer at each visit after BNPc
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
manual dexterity test
For an upper limb block, the dexterity will be evaluated by a Box and Block Test at each visit after BNPc
Assessment of activity limitation for a block of the upper limb
DASH scale at each visit
Assessment of activity limitation for a block of the lower limb
WOMAC score at each visit
Assessment of functional capacity
TDM6 at each visit (number of metres travelled by the patient during 6 minutes)
Assessment of the restriction of participation in social life
Return to work
Evaluation of the effective dose
- Recording of effective doses (continuous and bolus)
Evaluation of the tolerance of CPNB
- Incident reporting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04767646
Brief 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
Acronym
BLOCALGO
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pôle Saint Hélier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CRPS (Complex Regional Pain Syndrome) Type I
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
C-BNP with intensive rehabilitation program
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Intensive rehabilitation program with CPNB
Intervention Description
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
Primary Outcome Measure Information:
Title
The composite score (the summation of the 3 Goal Attainment Scaling (GAS) scores)
Description
The improvement of the composite score following BNPc combined with intensive rehabilitation.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Pain assessment
Description
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.
Time Frame
1 year
Title
Anxiety assessment
Description
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.
Time Frame
1 year
Title
Arthrometry assessment
Description
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)
Time Frame
1 year
Title
hand joint assessment
Description
For an upper limb block :
Kapandji Index at each visit (between 0 to 10)
Time Frame
1 year
Title
gripping force assessment
Description
For an upper limb block, gripping force will be evaluated with a Jamar and Pinch dynamometer at each visit after BNPc
Time Frame
1 year
Title
activity assessment
Description
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
Time Frame
1 year
Title
manual dexterity test
Description
For an upper limb block, the dexterity will be evaluated by a Box and Block Test at each visit after BNPc
Time Frame
1 year
Title
Assessment of activity limitation for a block of the upper limb
Description
DASH scale at each visit
Time Frame
1 year
Title
Assessment of activity limitation for a block of the lower limb
Description
WOMAC score at each visit
Time Frame
1 year
Title
Assessment of functional capacity
Description
TDM6 at each visit (number of metres travelled by the patient during 6 minutes)
Time Frame
1 year
Title
Assessment of the restriction of participation in social life
Description
Return to work
Time Frame
1 year
Title
Evaluation of the effective dose
Description
- Recording of effective doses (continuous and bolus)
Time Frame
During the CPNB
Title
Evaluation of the tolerance of CPNB
Description
- Incident reporting
Time Frame
During the CPNB
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Gallien, Doctor
Phone
0299295099
Email
philippe.gallien@pole-sthelier.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Gallien, Doctor
Organizational Affiliation
Pôle Saint Hélier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pôle Saint Hélier
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Gallien, Doctor
Email
philippe.gallien@pole-sthelier.com
12. IPD Sharing Statement
Learn more about this trial
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
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