Impact of Compression Garments on Pain in Patients With Complex Regional Pain Syndrome of the Upper Limbs. (VECODON)

October 1, 2025 updated by: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Marie-Caroline Delebecque, CRA
  • Phone Number: +33 02 97 82 62 93
  • Email: kerpape.arc@vyv3.fr

Study Locations

  • France
    • Brittany Region
      • Ploemeur, Brittany Region, France, 56270
        • Recruiting
        • CMRRF de Kerpape
        • Contact:
        • Principal Investigator:
          • Vincent Detaille, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: 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.
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).
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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:

  • 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.
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:

  • 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.
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:

  • 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.
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:

  • 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.
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:

  • 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.
At 1 year
Measurement of muscle strength in both hands
Time Frame: Day 0
  • the JAMAR® hydraulic hand dynamometer: measurement of the gripping force in kilograms
  • the PINCH® hydraulic pinch gauge: measures the pinch force in kilograms
Day 0
Measurement of muscle strength in both hands
Time Frame: At 1,5 months
  • the JAMAR® hydraulic hand dynamometer: measurement of the gripping force in kilograms
  • the PINCH® hydraulic pinch gauge: measures the pinch force in kilograms
At 1,5 months
Measurement of muscle strength in both hands
Time Frame: At 3 months
  • the JAMAR® hydraulic hand dynamometer: measurement of the gripping force in kilograms
  • the PINCH® hydraulic pinch gauge: measures the pinch force in kilograms
At 3 months
Measurement of muscle strength in both hands
Time Frame: At 6 months
  • the JAMAR® hydraulic hand dynamometer: measurement of the gripping force in kilograms
  • the PINCH® hydraulic pinch gauge: measures the pinch force in kilograms
At 6 months
Measurement of muscle strength in both hands
Time Frame: At 1 year
  • the JAMAR® hydraulic hand dynamometer: measurement of the gripping force in kilograms
  • the PINCH® hydraulic pinch gauge: measures the pinch force in kilograms
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fondation Rothschild Paris
Clinique Mutualiste Lorient
Groupement des Hôpitaux de l'Institut Catholique de Lille

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vincent Detaille, Doctor, CMRRF de Kerpape

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-A00657-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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