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

Complex Regional Pain Syndromes Clinical Trial

— VECODON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05034835
• Other study ID #: 2020-A00657-32
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: January 2025

Study information

• Verified date: October 2021
• Source: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
• Contact: Vincent Detaille, Doctor
• Phone: 02 97 82 60 28
• Email: vincent.detaille[@]vyv3.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

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:
• 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.

Locations

Country	Name	City	State
France	CMRRF de Kerpape	Ploemeur	Bretagne

Sponsors (4)

Lead Sponsor	Collaborator
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape	Clinique Mutualiste Lorient, Fondation Rothschild Paris, Groupement des Hôpitaux de l'Institut Catholique de Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 3 months
Secondary	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.	At 6 months
Secondary	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.	At 1 year
Secondary	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	Day 0
Secondary	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	At 1,5 months
Secondary	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	At 3 months
Secondary	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	At 6 months
Secondary	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	At 1 year
Secondary	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.	Day 0
Secondary	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.	At 1,5 months
Secondary	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.	At 3 months
Secondary	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.	At 6 months
Secondary	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.	At 1 year
Secondary	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.	Day 0
Secondary	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.	At 1,5 months
Secondary	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.	At 3 months
Secondary	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.	At 6 months
Secondary	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.	At 1 year
Secondary	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	Day 0
Secondary	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	At 1,5 months
Secondary	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	At 3 months
Secondary	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	At 6 months
Secondary	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	At 1 year
Secondary	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.	Day 0
Secondary	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.	At 1,5 months
Secondary	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.	At 3 months
Secondary	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.	At 6 months
Secondary	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.	At 1 year
Secondary	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.	Day 0
Secondary	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.	At 1,5 months
Secondary	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.	At 3 months
Secondary	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.	At 6 months
Secondary	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.	At 1 year
Secondary	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.	Day 0
Secondary	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.	At 1,5 months
Secondary	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.	At 3 months
Secondary	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.	At 6 months
Secondary	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.	At 1 year
Secondary	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.	Day 0
Secondary	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.	At 1,5 months
Secondary	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.	At 3 months
Secondary	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.	At 6 months
Secondary	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.	At 1 year
Secondary	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	Day 0
Secondary	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	At 1,5 months
Secondary	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	At 3 months
Secondary	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	At 6 months
Secondary	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	At 1 year
Secondary	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).	Day 0
Secondary	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).	At 1,5 months
Secondary	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).	At 3 months
Secondary	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).	At 6 months
Secondary	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).	At 1 year
Secondary	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.	Every week for 3 months
Secondary	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.	Every week for 3 months