Back to resultsImpact of Compression Garments on Pain in Patients With Complex Regional Pain Syndrome of the Upper Limbs. (VECODON)
Primary Purpose
Complex Regional Pain Syndromes
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
usual treatment with compression garments (CERECARE)
usual treatment without compression garments (CERECARE)
Sponsored by
About this trial
This is an interventional treatment trial for Complex Regional Pain Syndromes
Eligibility Criteria
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
Sites / Locations
- CMRRF de KerpapeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
With compression garments
Without compression garments
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Visual Analog Scale (VAS)
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.
Visual Analog Scale (VAS)
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.
Neuropathic Pain Symptom Inventory (NPSI)
It's a tool developed and validated in French, composed of 12 items. It provides an overall score and 5 sub-scores
Neuropathic Pain Symptom Inventory (NPSI)
It's a tool developed and validated in French, composed of 12 items. It provides an overall score and 5 sub-scores
Neuropathic Pain Symptom Inventory (NPSI)
It's a tool developed and validated in French, composed of 12 items. It provides an overall score and 5 sub-scores
Neuropathic Pain Symptom Inventory (NPSI)
It's a tool developed and validated in French, composed of 12 items. It provides an overall score and 5 sub-scores
Neuropathic Pain Symptom Inventory (NPSI)
It's a tool developed and validated in French, composed of 12 items. It provides an overall score and 5 sub-scores
Modification of analgesic drug treatment
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.
Modification of analgesic drug treatment
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.
Modification of analgesic drug treatment
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.
Modification of analgesic drug treatment
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.
Modification of analgesic drug treatment
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.
Measurement of range of motion
The range of motion is measured exploratory at different levels, for both sides:
Wrist range of motion, measured using posture foam and goniometer. This measures the amplitude in flexion, extension, radial tilt, ulnar tilt, and pronation and supination, both passively and actively.
Pulp-palm and pulp palmar fold distances of the fingers, measured using wedges of different lengths. One measurement is made per finger
Kapandji score, which is a score out of 10 based on achievable opposition for the thumb. 0 being the lowest score and 10 a normal score.
Measurement of range of motion
The range of motion is measured exploratory at different levels, for both sides:
Wrist range of motion, measured using posture foam and goniometer. This measures the amplitude in flexion, extension, radial tilt, ulnar tilt, and pronation and supination, both passively and actively.
Pulp-palm and pulp palmar fold distances of the fingers, measured using wedges of different lengths. One measurement is made per finger
Kapandji score, which is a score out of 10 based on achievable opposition for the thumb. 0 being the lowest score and 10 a normal score.
Measurement of range of motion
The range of motion is measured exploratory at different levels, for both sides:
Wrist range of motion, measured using posture foam and goniometer. This measures the amplitude in flexion, extension, radial tilt, ulnar tilt, and pronation and supination, both passively and actively.
Pulp-palm and pulp palmar fold distances of the fingers, measured using wedges of different lengths. One measurement is made per finger
Kapandji score, which is a score out of 10 based on achievable opposition for the thumb. 0 being the lowest score and 10 a normal score.
Measurement of range of motion
The range of motion is measured exploratory at different levels, for both sides:
Wrist range of motion, measured using posture foam and goniometer. This measures the amplitude in flexion, extension, radial tilt, ulnar tilt, and pronation and supination, both passively and actively.
Pulp-palm and pulp palmar fold distances of the fingers, measured using wedges of different lengths. One measurement is made per finger
Kapandji score, which is a score out of 10 based on achievable opposition for the thumb. 0 being the lowest score and 10 a normal score.
Measurement of range of motion
The range of motion is measured exploratory at different levels, for both sides:
Wrist range of motion, measured using posture foam and goniometer. This measures the amplitude in flexion, extension, radial tilt, ulnar tilt, and pronation and supination, both passively and actively.
Pulp-palm and pulp palmar fold distances of the fingers, measured using wedges of different lengths. One measurement is made per finger
Kapandji score, which is a score out of 10 based on achievable opposition for the thumb. 0 being the lowest score and 10 a normal score.
Measurement of muscle strength in both hands
the JAMAR® hydraulic hand dynamometer: measurement of the gripping force in kilograms
the PINCH® hydraulic pinch gauge: measures the pinch force in kilograms
Measurement of muscle strength in both hands
the JAMAR® hydraulic hand dynamometer: measurement of the gripping force in kilograms
the PINCH® hydraulic pinch gauge: measures the pinch force in kilograms
Measurement of muscle strength in both hands
the JAMAR® hydraulic hand dynamometer: measurement of the gripping force in kilograms
the PINCH® hydraulic pinch gauge: measures the pinch force in kilograms
Measurement of muscle strength in both hands
the JAMAR® hydraulic hand dynamometer: measurement of the gripping force in kilograms
the PINCH® hydraulic pinch gauge: measures the pinch force in kilograms
Measurement of muscle strength in both hands
the JAMAR® hydraulic hand dynamometer: measurement of the gripping force in kilograms
the PINCH® hydraulic pinch gauge: measures the pinch force in kilograms
Measurement of hand circumference
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.
Measurement of hand circumference
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.
Measurement of hand circumference
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.
Measurement of hand circumference
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.
Measurement of hand circumference
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.
Saint-Antoine Pain Questionnaire (QDSA)
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.
Saint-Antoine Pain Questionnaire (QDSA)
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.
Saint-Antoine Pain Questionnaire (QDSA)
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.
Saint-Antoine Pain Questionnaire (QDSA)
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.
Saint-Antoine Pain Questionnaire (QDSA)
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.
Cartographic assessment of pain
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.
Cartographic assessment of pain
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.
Cartographic assessment of pain
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.
Cartographic assessment of pain
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.
Cartographic assessment of pain
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.
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
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.
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
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.
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
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.
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
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.
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
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.
Hospital Anxiety and Depression (HAD) Scale
It comprises 14 items, allowing the obtaining of 2 scores out of 21 points, corresponding to the dimensions of anxiety and depression
Hospital Anxiety and Depression (HAD) Scale
It comprises 14 items, allowing the obtaining of 2 scores out of 21 points, corresponding to the dimensions of anxiety and depression
Hospital Anxiety and Depression (HAD) Scale
It comprises 14 items, allowing the obtaining of 2 scores out of 21 points, corresponding to the dimensions of anxiety and depression
Hospital Anxiety and Depression (HAD) Scale
It comprises 14 items, allowing the obtaining of 2 scores out of 21 points, corresponding to the dimensions of anxiety and depression
Hospital Anxiety and Depression (HAD) Scale
It comprises 14 items, allowing the obtaining of 2 scores out of 21 points, corresponding to the dimensions of anxiety and depression
The Short Form (36) Health Survey
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).
The Short Form (36) Health Survey
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).
The Short Form (36) Health Survey
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).
The Short Form (36) Health Survey
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).
The Short Form (36) Health Survey
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).
Observance of wearing the compression garment
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.
Tolerance of wearing the compression garment
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.
Full Information
NCT ID
NCT05034835
First Posted
August 26, 2021
Last Updated
October 19, 2021
Sponsor
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
Collaborators
Clinique Mutualiste Lorient, Fondation Rothschild Paris, Groupement des Hôpitaux de l'Institut Catholique de Lille
1. Study Identification
Unique Protocol Identification Number
NCT05034835
Brief Title
Impact of Compression Garments on Pain in Patients With Complex Regional Pain Syndrome of the Upper Limbs.
Acronym
VECODON
Official Title
Impact of Compression Garments on Neuropathic-looking Pain in Patients With Complex Regional Pain Syndrome (CRPS) of the Upper Limbs.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
Collaborators
Clinique Mutualiste Lorient, Fondation Rothschild Paris, Groupement des Hôpitaux de l'Institut Catholique de Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim is to study another alternative for the treatment of pain in people with CRPS. Indeed, the TRAB / Medullary occupational therapy department of the CMRRF in Kerpape used compression garments to reduce edema when it was present.In the case of CRPS of the upper limbs, gloves or compression sleeves are used to decrease the edema which is sometimes associated, although they are not supported for this indication. In this context, our clinical experience leads us to believe that there would also be some efficacy in neuropathic pain, this improvement being regularly described by patients.This study is expected to show a notable reduction in neuropathic pain thanks to the wearing of a compression garment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This research is part of a Research Involving the Human Person of the interventional type (RIPH1) and relates to a class I medical device (MD).
This is a single-center, controlled, randomized, open-label, superiority study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
With compression garments
Arm Type
Experimental
Arm Description
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.
Arm Title
Without compression garments
Arm Type
Other
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
usual treatment with compression garments (CERECARE)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
usual treatment without compression garments (CERECARE)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
At 6 months
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
At 1 year
Title
Neuropathic Pain Symptom Inventory (NPSI)
Description
It's a tool developed and validated in French, composed of 12 items. It provides an overall score and 5 sub-scores
Time Frame
Day 0
Title
Neuropathic Pain Symptom Inventory (NPSI)
Description
It's a tool developed and validated in French, composed of 12 items. It provides an overall score and 5 sub-scores
Time Frame
At 1,5 months
Title
Neuropathic Pain Symptom Inventory (NPSI)
Description
It's a tool developed and validated in French, composed of 12 items. It provides an overall score and 5 sub-scores
Time Frame
At 3 months
Title
Neuropathic Pain Symptom Inventory (NPSI)
Description
It's a tool developed and validated in French, composed of 12 items. It provides an overall score and 5 sub-scores
Time Frame
At 6 months
Title
Neuropathic Pain Symptom Inventory (NPSI)
Description
It's a tool developed and validated in French, composed of 12 items. It provides an overall score and 5 sub-scores
Time Frame
At 1 year
Title
Modification of analgesic drug treatment
Description
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.
Time Frame
Day 0
Title
Modification of analgesic drug treatment
Description
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.
Time Frame
At 1,5 months
Title
Modification of analgesic drug treatment
Description
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.
Time Frame
At 3 months
Title
Modification of analgesic drug treatment
Description
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.
Time Frame
At 6 months
Title
Modification of analgesic drug treatment
Description
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.
Time Frame
At 1 year
Title
Measurement of range of motion
Description
The range of motion is measured exploratory at different levels, for both sides:
Wrist range of motion, measured using posture foam and goniometer. This measures the amplitude in flexion, extension, radial tilt, ulnar tilt, and pronation and supination, both passively and actively.
Pulp-palm and pulp palmar fold distances of the fingers, measured using wedges of different lengths. One measurement is made per finger
Kapandji score, which is a score out of 10 based on achievable opposition for the thumb. 0 being the lowest score and 10 a normal score.
Time Frame
Day 0
Title
Measurement of range of motion
Description
The range of motion is measured exploratory at different levels, for both sides:
Wrist range of motion, measured using posture foam and goniometer. This measures the amplitude in flexion, extension, radial tilt, ulnar tilt, and pronation and supination, both passively and actively.
Pulp-palm and pulp palmar fold distances of the fingers, measured using wedges of different lengths. One measurement is made per finger
Kapandji score, which is a score out of 10 based on achievable opposition for the thumb. 0 being the lowest score and 10 a normal score.
Time Frame
At 1,5 months
Title
Measurement of range of motion
Description
The range of motion is measured exploratory at different levels, for both sides:
Wrist range of motion, measured using posture foam and goniometer. This measures the amplitude in flexion, extension, radial tilt, ulnar tilt, and pronation and supination, both passively and actively.
Pulp-palm and pulp palmar fold distances of the fingers, measured using wedges of different lengths. One measurement is made per finger
Kapandji score, which is a score out of 10 based on achievable opposition for the thumb. 0 being the lowest score and 10 a normal score.
Time Frame
At 3 months
Title
Measurement of range of motion
Description
The range of motion is measured exploratory at different levels, for both sides:
Wrist range of motion, measured using posture foam and goniometer. This measures the amplitude in flexion, extension, radial tilt, ulnar tilt, and pronation and supination, both passively and actively.
Pulp-palm and pulp palmar fold distances of the fingers, measured using wedges of different lengths. One measurement is made per finger
Kapandji score, which is a score out of 10 based on achievable opposition for the thumb. 0 being the lowest score and 10 a normal score.
Time Frame
At 6 months
Title
Measurement of range of motion
Description
The range of motion is measured exploratory at different levels, for both sides:
Wrist range of motion, measured using posture foam and goniometer. This measures the amplitude in flexion, extension, radial tilt, ulnar tilt, and pronation and supination, both passively and actively.
Pulp-palm and pulp palmar fold distances of the fingers, measured using wedges of different lengths. One measurement is made per finger
Kapandji score, which is a score out of 10 based on achievable opposition for the thumb. 0 being the lowest score and 10 a normal score.
Time Frame
At 1 year
Title
Measurement of muscle strength in both hands
Description
the JAMAR® hydraulic hand dynamometer: measurement of the gripping force in kilograms
the PINCH® hydraulic pinch gauge: measures the pinch force in kilograms
Time Frame
Day 0
Title
Measurement of muscle strength in both hands
Description
the JAMAR® hydraulic hand dynamometer: measurement of the gripping force in kilograms
the PINCH® hydraulic pinch gauge: measures the pinch force in kilograms
Time Frame
At 1,5 months
Title
Measurement of muscle strength in both hands
Description
the JAMAR® hydraulic hand dynamometer: measurement of the gripping force in kilograms
the PINCH® hydraulic pinch gauge: measures the pinch force in kilograms
Time Frame
At 3 months
Title
Measurement of muscle strength in both hands
Description
the JAMAR® hydraulic hand dynamometer: measurement of the gripping force in kilograms
the PINCH® hydraulic pinch gauge: measures the pinch force in kilograms
Time Frame
At 6 months
Title
Measurement of muscle strength in both hands
Description
the JAMAR® hydraulic hand dynamometer: measurement of the gripping force in kilograms
the PINCH® hydraulic pinch gauge: measures the pinch force in kilograms
Time Frame
At 1 year
Title
Measurement of hand circumference
Description
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.
Time Frame
Day 0
Title
Measurement of hand circumference
Description
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.
Time Frame
At 1,5 months
Title
Measurement of hand circumference
Description
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.
Time Frame
At 3 months
Title
Measurement of hand circumference
Description
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.
Time Frame
At 6 months
Title
Measurement of hand circumference
Description
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.
Time Frame
At 1 year
Title
Saint-Antoine Pain Questionnaire (QDSA)
Description
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.
Time Frame
Day 0
Title
Saint-Antoine Pain Questionnaire (QDSA)
Description
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.
Time Frame
At 1,5 months
Title
Saint-Antoine Pain Questionnaire (QDSA)
Description
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.
Time Frame
At 3 months
Title
Saint-Antoine Pain Questionnaire (QDSA)
Description
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.
Time Frame
At 6 months
Title
Saint-Antoine Pain Questionnaire (QDSA)
Description
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.
Time Frame
At 1 year
Title
Cartographic assessment of pain
Description
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.
Time Frame
Day 0
Title
Cartographic assessment of pain
Description
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.
Time Frame
At 1,5 months
Title
Cartographic assessment of pain
Description
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.
Time Frame
At 3 months
Title
Cartographic assessment of pain
Description
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.
Time Frame
At 6 months
Title
Cartographic assessment of pain
Description
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.
Time Frame
At 1 year
Title
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Description
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.
Time Frame
Day 0
Title
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Description
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.
Time Frame
At 1,5 months
Title
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Description
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.
Time Frame
At 3 months
Title
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Description
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.
Time Frame
At 6 months
Title
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Description
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.
Time Frame
At 1 year
Title
Hospital Anxiety and Depression (HAD) Scale
Description
It comprises 14 items, allowing the obtaining of 2 scores out of 21 points, corresponding to the dimensions of anxiety and depression
Time Frame
Day 0
Title
Hospital Anxiety and Depression (HAD) Scale
Description
It comprises 14 items, allowing the obtaining of 2 scores out of 21 points, corresponding to the dimensions of anxiety and depression
Time Frame
At 1,5 months
Title
Hospital Anxiety and Depression (HAD) Scale
Description
It comprises 14 items, allowing the obtaining of 2 scores out of 21 points, corresponding to the dimensions of anxiety and depression
Time Frame
At 3 months
Title
Hospital Anxiety and Depression (HAD) Scale
Description
It comprises 14 items, allowing the obtaining of 2 scores out of 21 points, corresponding to the dimensions of anxiety and depression
Time Frame
At 6 months
Title
Hospital Anxiety and Depression (HAD) Scale
Description
It comprises 14 items, allowing the obtaining of 2 scores out of 21 points, corresponding to the dimensions of anxiety and depression
Time Frame
At 1 year
Title
The Short Form (36) Health Survey
Description
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).
Time Frame
Day 0
Title
The Short Form (36) Health Survey
Description
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).
Time Frame
At 1,5 months
Title
The Short Form (36) Health Survey
Description
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).
Time Frame
At 3 months
Title
The Short Form (36) Health Survey
Description
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).
Time Frame
At 6 months
Title
The Short Form (36) Health Survey
Description
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).
Time Frame
At 1 year
Title
Observance of wearing the compression garment
Description
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.
Time Frame
Every week for 3 months
Title
Tolerance of wearing the compression garment
Description
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.
Time Frame
Every week for 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Detaille, Doctor
Phone
02 97 82 60 28
Ext
+33
Email
vincent.detaille@vyv3.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Caroline Delebecque, CRA
Phone
02 97 82 62 93
Ext
+33
Email
kerpape.arc@vyv3.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Detaille, Doctor
Organizational Affiliation
CMRRF de Kerpape
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMRRF de Kerpape
City
Ploemeur
State/Province
Bretagne
ZIP/Postal Code
56270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Caroline Delebecque, CRA
Phone
02 97 82 62 93
Ext
+33
Email
kerpape.arc@vyv3.fr
First Name & Middle Initial & Last Name & Degree
Vincent Detaille, Doctor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Compression Garments on Pain in Patients With Complex Regional Pain Syndrome of the Upper Limbs.
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