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NCT Number: NCT05034835

Impact of Compression Garments on Pain in Patients With Complex Regional Pain Syndrome 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.

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Key information

Conditions

Complex Regional Pain Syndromes Autonomic Nervous System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CMRRF de Kerpape

Ploemeur, Brittany Region, 56270, France

Location status: Recruiting

Location contact

Marie-Caroline Delebecque, CRA

CONTACT

[email protected]

02 97 82 62 93 ext. +33

Vincent Detaille, Doctor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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

  44. 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

  45. 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

  46. 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

  47. 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

  48. 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).

  49. 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).

  50. 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).

  51. 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).

  52. 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).

  53. 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.

  54. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Caroline Delebecque, CRA

CONTACT

[email protected]

02 97 82 62 93 ext. +33

Vincent Detaille, Doctor

CONTACT

[email protected]

02 97 82 60 28 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Other

Collaborators

  • Clinique Mutualiste Lorient
  • Fondation Rothschild Paris
  • Groupement des Hôpitaux de l'Institut Catholique de Lille

Registry information

Official study title

Impact of Compression Garments on Neuropathic-looking Pain in Patients With Complex Regional Pain Syndrome (CRPS) of the Upper Limbs.

Acronym: VECODON

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2021
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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