- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05034835
Impact of Compression Garments on Pain in Patients With Complex Regional Pain Syndrome of the Upper Limbs. (VECODON)
Impact of Compression Garments on Neuropathic-looking Pain in Patients With Complex Regional Pain Syndrome (CRPS) of the Upper Limbs.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vincent Detaille, Doctor
- Phone Number: +33 02 97 82 60 28
- Email: vincent.detaille@vyv3.fr
Study Contact Backup
- Name: Marie-Caroline Delebecque, CRA
- Phone Number: +33 02 97 82 62 93
- Email: kerpape.arc@vyv3.fr
Study Locations
-
-
Bretagne
-
Ploemeur, Bretagne, France, 56270
- Recruiting
- CMRRF de Kerpape
-
Contact:
- Marie-Caroline Delebecque, CRA
- Phone Number: +33 02 97 82 62 93
- Email: kerpape.arc@vyv3.fr
-
Principal Investigator:
- Vincent Detaille, Doctor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients with CRPS of the upper limb with neuropathic pain
- Diagnosis of CRPS according to the Budapest criteria
- Diagnosis of neuropathic pain according to DN4
- CRPS evolving for more than 3 months
- No phlebitis or open sores on the upper limbs
- Patient consent to participate in the study
- No modification of his drug treatment for 1 month
- Affiliation to a social security scheme or beneficiary of such a scheme
Exclusion Criteria:
- Patient under guardianship, curatorship or safeguard of justice
- Psychiatric pathology altering the ability to consent
- Severe cognitive disorders that do not allow the patient to assess his pain
- Skin pathology preventing the wearing of the compression garment
- Patient who has previously worn a compression garment
- History of vascular disorders of the upper limbs, lymph node dissection, or any other pathology that can lead to edema regardless of CRPS
- Known allergy to one of the components of the compression garments of the Cerecare brand
- Declared pregnancy, breastfeeding woman or woman of childbearing potential without contraception
- Inability to put on the compression garment alone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: With compression garments
Usual care in day hospitals, i.e. 3 occupational therapy sessions / week for 3 months, with the usual protocol of desensitization by Aquaroll (hydro-massage ball device) and by Vibralgic (device generating electronic transcutaneous vibrations) + wearing a compression garment for 3 months.
|
For 3 months, the pain will be assessed every week, tolerance and compliance with compression garments will also be monitored.
Participants will be reviewed specifically at a follow-up consultation for the 6-month and 1-year study.
Various assessments will be carried out during these visits : assessment of pain, range of motion, muscle strength, sensitivity test, assessment of anxiety, depression and even quality of life.
|
Other: Without compression garments
Usual care in day hospitals, i.e. 3 occupational therapy sessions / week for 3 months, with the usual protocol of desensitization by Aquaroll (hydro-massage ball device) and by Vibralgic (device generating electronic transcutaneous vibrations).
|
For 3 months, the pain will be assessed every week, tolerance and compliance with compression garments will also be monitored.
Participants will be reviewed specifically at a follow-up consultation for the 6-month and 1-year study.
Various assessments will be carried out during these visits : assessment of pain, range of motion, muscle strength, sensitivity test, assessment of anxiety, depression and even quality of life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The evolution of pain through Visual Analog Scale (VAS), measured every week for 3 months in the last 24 hours and in the last 7 days
Time Frame: up to 3 months
|
The VAS is a self-rated scale.
It comes in the form of a 10 cm plastic ruler graduated in mm.
On the face presented to the patient is a cursor which he moves along a straight line, one end of which corresponds to "No pain" and the other to "Maximum pain imaginable".
The patient should, along this line, position the cursor where the pain is best located.
On the other side, there are millimeter graduations seen only by the caregiver.
The position of the cursor mobilized by the patient makes it possible to read the intensity of the pain, which is measured in mm.
|
up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: At 6 months
|
The VAS is a self-rated scale.
It comes in the form of a 10 cm plastic ruler graduated in mm.
On the face presented to the patient is a cursor which he moves along a straight line, one end of which corresponds to "No pain" and the other to "Maximum pain imaginable".
The patient should, along this line, position the cursor where the pain is best located.
On the other side, there are millimeter graduations seen only by the caregiver.
The position of the cursor mobilized by the patient makes it possible to read the intensity of the pain, which is measured in mm.
|
At 6 months
|
Visual Analog Scale (VAS)
Time Frame: At 1 year
|
The VAS is a self-rated scale.
It comes in the form of a 10 cm plastic ruler graduated in mm.
On the face presented to the patient is a cursor which he moves along a straight line, one end of which corresponds to "No pain" and the other to "Maximum pain imaginable".
The patient should, along this line, position the cursor where the pain is best located.
On the other side, there are millimeter graduations seen only by the caregiver.
The position of the cursor mobilized by the patient makes it possible to read the intensity of the pain, which is measured in mm.
|
At 1 year
|
Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: Day 0
|
It's a tool developed and validated in French, composed of 12 items.
It provides an overall score and 5 sub-scores
|
Day 0
|
Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: At 1,5 months
|
It's a tool developed and validated in French, composed of 12 items.
It provides an overall score and 5 sub-scores
|
At 1,5 months
|
Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: At 3 months
|
It's a tool developed and validated in French, composed of 12 items.
It provides an overall score and 5 sub-scores
|
At 3 months
|
Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: At 6 months
|
It's a tool developed and validated in French, composed of 12 items.
It provides an overall score and 5 sub-scores
|
At 6 months
|
Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: At 1 year
|
It's a tool developed and validated in French, composed of 12 items.
It provides an overall score and 5 sub-scores
|
At 1 year
|
Modification of analgesic drug treatment
Time Frame: Day 0
|
The increase or decrease in doses between each visit will be collected by the doctor.
He can rely on the booklet filled out by the patient.
|
Day 0
|
Modification of analgesic drug treatment
Time Frame: At 1,5 months
|
The increase or decrease in doses between each visit will be collected by the doctor.
He can rely on the booklet filled out by the patient.
|
At 1,5 months
|
Modification of analgesic drug treatment
Time Frame: At 3 months
|
The increase or decrease in doses between each visit will be collected by the doctor.
He can rely on the booklet filled out by the patient.
|
At 3 months
|
Modification of analgesic drug treatment
Time Frame: At 6 months
|
The increase or decrease in doses between each visit will be collected by the doctor.
He can rely on the booklet filled out by the patient.
|
At 6 months
|
Modification of analgesic drug treatment
Time Frame: At 1 year
|
The increase or decrease in doses between each visit will be collected by the doctor.
He can rely on the booklet filled out by the patient.
|
At 1 year
|
Measurement of range of motion
Time Frame: Day 0
|
The range of motion is measured exploratory at different levels, for both sides:
|
Day 0
|
Measurement of range of motion
Time Frame: At 1,5 months
|
The range of motion is measured exploratory at different levels, for both sides:
|
At 1,5 months
|
Measurement of range of motion
Time Frame: At 3 months
|
The range of motion is measured exploratory at different levels, for both sides:
|
At 3 months
|
Measurement of range of motion
Time Frame: At 6 months
|
The range of motion is measured exploratory at different levels, for both sides:
|
At 6 months
|
Measurement of range of motion
Time Frame: At 1 year
|
The range of motion is measured exploratory at different levels, for both sides:
|
At 1 year
|
Measurement of muscle strength in both hands
Time Frame: Day 0
|
|
Day 0
|
Measurement of muscle strength in both hands
Time Frame: At 1,5 months
|
|
At 1,5 months
|
Measurement of muscle strength in both hands
Time Frame: At 3 months
|
|
At 3 months
|
Measurement of muscle strength in both hands
Time Frame: At 6 months
|
|
At 6 months
|
Measurement of muscle strength in both hands
Time Frame: At 1 year
|
|
At 1 year
|
Measurement of hand circumference
Time Frame: Day 0
|
The circumference of the hand is measured in different places. A total of 15 measurements are taken. Both hands are measured. The analysis will be based on the difference of the sum of the 15 measures for each of the hands. |
Day 0
|
Measurement of hand circumference
Time Frame: At 1,5 months
|
The circumference of the hand is measured in different places. A total of 15 measurements are taken. Both hands are measured. The analysis will be based on the difference of the sum of the 15 measures for each of the hands. |
At 1,5 months
|
Measurement of hand circumference
Time Frame: At 3 months
|
The circumference of the hand is measured in different places. A total of 15 measurements are taken. Both hands are measured. The analysis will be based on the difference of the sum of the 15 measures for each of the hands. |
At 3 months
|
Measurement of hand circumference
Time Frame: At 6 months
|
The circumference of the hand is measured in different places. A total of 15 measurements are taken. Both hands are measured. The analysis will be based on the difference of the sum of the 15 measures for each of the hands. |
At 6 months
|
Measurement of hand circumference
Time Frame: At 1 year
|
The circumference of the hand is measured in different places. A total of 15 measurements are taken. Both hands are measured. The analysis will be based on the difference of the sum of the 15 measures for each of the hands. |
At 1 year
|
Saint-Antoine Pain Questionnaire (QDSA)
Time Frame: Day 0
|
Illustrating the different components of pain, the QDSA (French version of the Mac Gill Pain Questionnary-MPQ) essentially allows a qualitative assessment of chronic pain, in particular neuropathic pain.
It is a questionnaire of 58 qualifying words divided into subclasses: sensory pain on the one hand, affective and emotional pain on the other.
The patient is asked to select the adjectives corresponding to his pain and then to note them from 0 (absent) to 4 (very strong).
This self-assessment scale makes it possible in clinical practice to specify the involvement of the sensory and the emotional in pain intensity.
|
Day 0
|
Saint-Antoine Pain Questionnaire (QDSA)
Time Frame: At 1,5 months
|
Illustrating the different components of pain, the QDSA (French version of the Mac Gill Pain Questionnary-MPQ) essentially allows a qualitative assessment of chronic pain, in particular neuropathic pain.
It is a questionnaire of 58 qualifying words divided into subclasses: sensory pain on the one hand, affective and emotional pain on the other.
The patient is asked to select the adjectives corresponding to his pain and then to note them from 0 (absent) to 4 (very strong).
This self-assessment scale makes it possible in clinical practice to specify the involvement of the sensory and the emotional in pain intensity.
|
At 1,5 months
|
Saint-Antoine Pain Questionnaire (QDSA)
Time Frame: At 3 months
|
Illustrating the different components of pain, the QDSA (French version of the Mac Gill Pain Questionnary-MPQ) essentially allows a qualitative assessment of chronic pain, in particular neuropathic pain.
It is a questionnaire of 58 qualifying words divided into subclasses: sensory pain on the one hand, affective and emotional pain on the other.
The patient is asked to select the adjectives corresponding to his pain and then to note them from 0 (absent) to 4 (very strong).
This self-assessment scale makes it possible in clinical practice to specify the involvement of the sensory and the emotional in pain intensity.
|
At 3 months
|
Saint-Antoine Pain Questionnaire (QDSA)
Time Frame: At 6 months
|
Illustrating the different components of pain, the QDSA (French version of the Mac Gill Pain Questionnary-MPQ) essentially allows a qualitative assessment of chronic pain, in particular neuropathic pain.
It is a questionnaire of 58 qualifying words divided into subclasses: sensory pain on the one hand, affective and emotional pain on the other.
The patient is asked to select the adjectives corresponding to his pain and then to note them from 0 (absent) to 4 (very strong).
This self-assessment scale makes it possible in clinical practice to specify the involvement of the sensory and the emotional in pain intensity.
|
At 6 months
|
Saint-Antoine Pain Questionnaire (QDSA)
Time Frame: At 1 year
|
Illustrating the different components of pain, the QDSA (French version of the Mac Gill Pain Questionnary-MPQ) essentially allows a qualitative assessment of chronic pain, in particular neuropathic pain.
It is a questionnaire of 58 qualifying words divided into subclasses: sensory pain on the one hand, affective and emotional pain on the other.
The patient is asked to select the adjectives corresponding to his pain and then to note them from 0 (absent) to 4 (very strong).
This self-assessment scale makes it possible in clinical practice to specify the involvement of the sensory and the emotional in pain intensity.
|
At 1 year
|
Cartographic assessment of pain
Time Frame: Day 0
|
The cartographic assessment of pain is carried out following the QDSA.
Using schematic representations of the hand (dorsal face and palmar face for each hand), the patient locates and describes his pain.
|
Day 0
|
Cartographic assessment of pain
Time Frame: At 1,5 months
|
The cartographic assessment of pain is carried out following the QDSA.
Using schematic representations of the hand (dorsal face and palmar face for each hand), the patient locates and describes his pain.
|
At 1,5 months
|
Cartographic assessment of pain
Time Frame: At 3 months
|
The cartographic assessment of pain is carried out following the QDSA.
Using schematic representations of the hand (dorsal face and palmar face for each hand), the patient locates and describes his pain.
|
At 3 months
|
Cartographic assessment of pain
Time Frame: At 6 months
|
The cartographic assessment of pain is carried out following the QDSA.
Using schematic representations of the hand (dorsal face and palmar face for each hand), the patient locates and describes his pain.
|
At 6 months
|
Cartographic assessment of pain
Time Frame: At 1 year
|
The cartographic assessment of pain is carried out following the QDSA.
Using schematic representations of the hand (dorsal face and palmar face for each hand), the patient locates and describes his pain.
|
At 1 year
|
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Time Frame: Day 0
|
This is a subjective self-assessment questionnaire of the overall functional capacity of the two upper limbs, composed of 30 items, rated from 1 to 5 depending on the difficulty of the task described, leading to a score out of 100.
|
Day 0
|
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Time Frame: At 1,5 months
|
This is a subjective self-assessment questionnaire of the overall functional capacity of the two upper limbs, composed of 30 items, rated from 1 to 5 depending on the difficulty of the task described, leading to a score out of 100.
|
At 1,5 months
|
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Time Frame: At 3 months
|
This is a subjective self-assessment questionnaire of the overall functional capacity of the two upper limbs, composed of 30 items, rated from 1 to 5 depending on the difficulty of the task described, leading to a score out of 100.
|
At 3 months
|
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Time Frame: At 6 months
|
This is a subjective self-assessment questionnaire of the overall functional capacity of the two upper limbs, composed of 30 items, rated from 1 to 5 depending on the difficulty of the task described, leading to a score out of 100.
|
At 6 months
|
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Time Frame: At 1 year
|
This is a subjective self-assessment questionnaire of the overall functional capacity of the two upper limbs, composed of 30 items, rated from 1 to 5 depending on the difficulty of the task described, leading to a score out of 100.
|
At 1 year
|
Hospital Anxiety and Depression (HAD) Scale
Time Frame: Day 0
|
It comprises 14 items, allowing the obtaining of 2 scores out of 21 points, corresponding to the dimensions of anxiety and depression
|
Day 0
|
Hospital Anxiety and Depression (HAD) Scale
Time Frame: At 1,5 months
|
It comprises 14 items, allowing the obtaining of 2 scores out of 21 points, corresponding to the dimensions of anxiety and depression
|
At 1,5 months
|
Hospital Anxiety and Depression (HAD) Scale
Time Frame: At 3 months
|
It comprises 14 items, allowing the obtaining of 2 scores out of 21 points, corresponding to the dimensions of anxiety and depression
|
At 3 months
|
Hospital Anxiety and Depression (HAD) Scale
Time Frame: At 6 months
|
It comprises 14 items, allowing the obtaining of 2 scores out of 21 points, corresponding to the dimensions of anxiety and depression
|
At 6 months
|
Hospital Anxiety and Depression (HAD) Scale
Time Frame: At 1 year
|
It comprises 14 items, allowing the obtaining of 2 scores out of 21 points, corresponding to the dimensions of anxiety and depression
|
At 1 year
|
The Short Form (36) Health Survey
Time Frame: Day 0
|
This is a standardized test for measuring the quality of life.
It includes 36 items divided into 8 dimensions (physical functioning, role limitations related to physical health, physical pain, general health, vitality [energy / fatigue], functioning or social well-being, role limitations related to mental health, Mental Health).
|
Day 0
|
The Short Form (36) Health Survey
Time Frame: At 1,5 months
|
This is a standardized test for measuring the quality of life.
It includes 36 items divided into 8 dimensions (physical functioning, role limitations related to physical health, physical pain, general health, vitality [energy / fatigue], functioning or social well-being, role limitations related to mental health, Mental Health).
|
At 1,5 months
|
The Short Form (36) Health Survey
Time Frame: At 3 months
|
This is a standardized test for measuring the quality of life.
It includes 36 items divided into 8 dimensions (physical functioning, role limitations related to physical health, physical pain, general health, vitality [energy / fatigue], functioning or social well-being, role limitations related to mental health, Mental Health).
|
At 3 months
|
The Short Form (36) Health Survey
Time Frame: At 6 months
|
This is a standardized test for measuring the quality of life.
It includes 36 items divided into 8 dimensions (physical functioning, role limitations related to physical health, physical pain, general health, vitality [energy / fatigue], functioning or social well-being, role limitations related to mental health, Mental Health).
|
At 6 months
|
The Short Form (36) Health Survey
Time Frame: At 1 year
|
This is a standardized test for measuring the quality of life.
It includes 36 items divided into 8 dimensions (physical functioning, role limitations related to physical health, physical pain, general health, vitality [energy / fatigue], functioning or social well-being, role limitations related to mental health, Mental Health).
|
At 1 year
|
Observance of wearing the compression garment
Time Frame: Every week for 3 months
|
Compliance with the wearing of the compression garment will be measured by the average number of hours of wearing the garment per day, which will be evaluated on the patient's statements in the experimental arm during the visits.
|
Every week for 3 months
|
Tolerance of wearing the compression garment
Time Frame: Every week for 3 months
|
The tolerance of wearing the compression garment will be assessed by recording the presence of irritation or surface skin lesion, compression felt as being too unpleasant or even unbearable by the patient in the experimental arm and leading to stopping wearing.
|
Every week for 3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Vincent Detaille, Doctor, CMRRF de Kerpape
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-A00657-32
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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