Complex Regional Pain SyndromesVECODONNCT05034835
Impact of Compression Garments on Pain in Patients With Complex Regional Pain Syndrome of the Upper Limbs.
A study testing usual treatment with compression garments (CERECARE) and usual treatment without compression garments (CERECARE) in people with Complex Regional Pain Syndromes, run by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- usual treatment with compression garments (CERECARE) and usual treatment without compression garments (CERECARE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2021to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CMRRF de Kerpape
Ploemeur, Brittany Region, 56270
Marie-Caroline Delebecque, CRA, 02 97 82 62 93 ext. +33, kerpape.arc@vyv3.fr
Vincent Detaille, Doctor
About this study
Official title: Impact of Compression Garments on Neuropathic-looking Pain in Patients With Complex Regional Pain Syndrome (CRPS) of the Upper Limbs.
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.
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- usual treatment with compression garments (CERECARE), usual treatment without compression garments (CERECARE)
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual treatment with compression garments (CERECARE)Device
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.
usual treatment without compression garments (CERECARE)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| With compression garments | Experimental | 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. Receives: Device: usual treatment with compression garments (CERECARE) |
| Without compression garments | Other | 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). Receives: Other: usual treatment without compression garments (CERECARE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 months
Secondary outcomes (54)
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.
Measured: At 6 months
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.
Measured: At 1 year
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
Measured: Day 0
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
Measured: At 1,5 months
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
Measured: At 3 months
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
Measured: At 6 months
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
Measured: At 1 year
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.
Measured: Day 0
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.
Measured: At 1,5 months
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.
Measured: At 3 months
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.
Measured: At 6 months
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.
Measured: At 1 year
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.
Measured: Day 0
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.
Measured: At 1,5 months
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.
Measured: At 3 months
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.
Measured: At 6 months
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.
Measured: At 1 year
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
Measured: Day 0
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
Measured: At 1,5 months
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
Measured: At 3 months
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
Measured: At 6 months
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
Measured: At 1 year
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.
Measured: Day 0
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.
Measured: At 1,5 months
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.
Measured: At 3 months
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.
Measured: At 6 months
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.
Measured: At 1 year
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.
Measured: Day 0
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.
Measured: At 1,5 months
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.
Measured: At 3 months
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.
Measured: At 6 months
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.
Measured: At 1 year
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.
Measured: Day 0
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.
Measured: At 1,5 months
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.
Measured: At 3 months
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.
Measured: At 6 months
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.
Measured: At 1 year
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.
Measured: Day 0
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.
Measured: At 1,5 months
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.
Measured: At 3 months
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.
Measured: At 6 months
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.
Measured: At 1 year
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
Measured: Day 0
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
Measured: At 1,5 months
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
Measured: At 3 months
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
Measured: At 6 months
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
Measured: At 1 year
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).
Measured: Day 0
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).
Measured: At 1,5 months
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).
Measured: At 3 months
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).
Measured: At 6 months
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).
Measured: At 1 year
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.
Measured: Every week for 3 months
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.
Measured: Every week for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start12 Oct 2021
- Primary completionMay 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique Mutualiste Lorient, Fondation Rothschild Paris, Groupement des Hôpitaux de l'Institut Catholique de Lille
- Responsible party
- Sponsor
- Investigators
- Vincent Detaille, Doctor, Principal investigator, CMRRF de Kerpape
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034835
- Sponsor's protocol ID
- 2020-A00657-32
- Acronym
- VECODON
- Status last verified
- Oct 2025
- First submitted
- 26 Aug 2021
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Compression Garments on Neuropathic-looking Pain in Patients With Complex Regional Pain Syndrome (CRPS) of the Upper Limbs.
- ClinicalTrials.gov ID
- NCT05034835
- Acronym / sponsor ID
- VECODON / 2020-A00657-32
- Conditions
- Complex Regional Pain Syndromes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KerpapeUniversity, hospital or other
- Collaborators
- Clinique Mutualiste Lorient, Fondation Rothschild Paris, Groupement des Hôpitaux de l'Institut Catholique de Lille
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| With compression garments | Experimental | Device: usual treatment with compression garments (CERECARE)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. |
| Without compression garments | Other | Other: usual treatment without compression garments (CERECARE)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with CRPS of the upper limb with neuropathic pain
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usual treatment with compression garments (CERECARE)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. | Device | With compression garments |
| usual treatment without compression garments (CERECARE)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 |
Primary outcome
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.
54 secondary outcomes
Visual Analog Scale (VAS)
Time frame: At 6 months
Visual Analog Scale (VAS)
Time frame: At 1 year
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: Day 0
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: At 1,5 months
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: At 3 months
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: At 6 months
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: At 1 year
Modification of analgesic drug treatment
Time frame: Day 0
Modification of analgesic drug treatment
Time frame: At 1,5 months
Modification of analgesic drug treatment
Time frame: At 3 months
Modification of analgesic drug treatment
Time frame: At 6 months
Modification of analgesic drug treatment
Time frame: At 1 year
Measurement of range of motion
Time frame: Day 0
Measurement of range of motion
Time frame: At 1,5 months
Measurement of range of motion
Time frame: At 3 months
Measurement of range of motion
Time frame: At 6 months
Measurement of range of motion
Time frame: At 1 year
Measurement of muscle strength in both hands
Time frame: Day 0
Measurement of muscle strength in both hands
Time frame: At 1,5 months
Measurement of muscle strength in both hands
Time frame: At 3 months
Measurement of muscle strength in both hands
Time frame: At 6 months
Measurement of muscle strength in both hands
Time frame: At 1 year
Measurement of hand circumference
Time frame: Day 0
Measurement of hand circumference
Time frame: At 1,5 months
Measurement of hand circumference
Time frame: At 3 months
Measurement of hand circumference
Time frame: At 6 months
Measurement of hand circumference
Time frame: At 1 year
Saint-Antoine Pain Questionnaire (QDSA)
Time frame: Day 0
Saint-Antoine Pain Questionnaire (QDSA)
Time frame: At 1,5 months
Saint-Antoine Pain Questionnaire (QDSA)
Time frame: At 3 months
Saint-Antoine Pain Questionnaire (QDSA)
Time frame: At 6 months
Saint-Antoine Pain Questionnaire (QDSA)
Time frame: At 1 year
Cartographic assessment of pain
Time frame: Day 0
Cartographic assessment of pain
Time frame: At 1,5 months
Cartographic assessment of pain
Time frame: At 3 months
Cartographic assessment of pain
Time frame: At 6 months
Cartographic assessment of pain
Time frame: At 1 year
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Time frame: Day 0
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Time frame: At 1,5 months
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Time frame: At 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent Detaille, Doctor principal investigator
CMRRF de Kerpape
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing usual treatment with compression garments (CERECARE) and usual treatment without compression garments (CERECARE) in people with Complex Regional Pain Syndromes, run by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent Detaille, Doctor (02 97 82 60 28 ext. +33, vincent.detaille@vyv3.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.