Clinical trial NCT05034835: Impact of Compression Garments on Pain in Patients With Complex Regional Pain Syndrome of the Upper Limbs.
Official title: Impact of Compression Garments on Neuropathic-looking Pain in Patients With Complex Regional Pain Syndrome (CRPS) of the Upper Limbs.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complex Regional Pain Syndromes
Lead sponsor: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
Sponsor class: OTHER
Collaborators: name: Clinique Mutualiste Lorient
name: Fondation Rothschild Paris
name: Groupement des Hôpitaux de l'Institut Catholique de Lille
First posted: 2021-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: The aim is to study another alternative for the treatment of pain in people with CRPS. Indeed, the TRAB / Medullary occupational therapy department of the CMRRF in Kerpape used compression garments to reduce edema when it was present.In the case of CRPS of the upper limbs, gloves or compression sleeves are used to decrease the edema which is sometimes associated, although they are not supported for this indication. In this context, our clinical experience leads us to believe that there would also be some efficacy in neuropathic pain, this improvement being regularly described by patients.This study is expected to show a notable reduction in neuropathic pain thanks to the wearing of a compression garment.


Eligibility criteria: Inclusion Criteria:

* Patients with CRPS of the upper limb with neuropathic pain

  * Diagnosis of CRPS according to the Budapest criteria
  * Diagnosis of neuropathic pain according to DN4
* CRPS evolving for more than 3 months
* No phlebitis or open sores on the upper limbs
* Patient consent to participate in the study
* No modification of his drug treatment for 1 month
* Affiliation to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

* Patient under guardianship, curatorship or safeguard of justice
* Psychiatric pathology altering the ability to consent
* Severe cognitive disorders that do not allow the patient to assess his pain
* Skin pathology preventing the wearing of the compression garment
* Patient who has previously worn a compression garment
* History of vascular disorders of the upper limbs, lymph node dissection, or any other pathology that can lead to edema regardless of CRPS
* Known allergy to one of the components of the compression garments of the Cerecare brand
* Declared pregnancy, breastfeeding woman or woman of childbearing potential without contraception
* Inability to put on the compression garment alone

Primary outcomes:
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
timeFrame: up to 3 months
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: At 6 months
measure: Visual Analog Scale (VAS)
timeFrame: At 1 year
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Day 0
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: At 1,5 months
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: At 3 months
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: At 6 months
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: At 1 year
measure: Modification of analgesic drug treatment
timeFrame: Day 0
measure: Modification of analgesic drug treatment
timeFrame: At 1,5 months
measure: Modification of analgesic drug treatment
timeFrame: At 3 months
measure: Modification of analgesic drug treatment
timeFrame: At 6 months
measure: Modification of analgesic drug treatment
timeFrame: At 1 year
measure: Measurement of range of motion
timeFrame: Day 0
measure: Measurement of range of motion
timeFrame: At 1,5 months
measure: Measurement of range of motion
timeFrame: At 3 months
measure: Measurement of range of motion
timeFrame: At 6 months
measure: Measurement of range of motion
timeFrame: At 1 year
measure: Measurement of muscle strength in both hands
timeFrame: Day 0
measure: Measurement of muscle strength in both hands
timeFrame: At 1,5 months
measure: Measurement of muscle strength in both hands
timeFrame: At 3 months
measure: Measurement of muscle strength in both hands
timeFrame: At 6 months
measure: Measurement of muscle strength in both hands
timeFrame: At 1 year
measure: Measurement of hand circumference
timeFrame: Day 0
measure: Measurement of hand circumference
timeFrame: At 1,5 months
measure: Measurement of hand circumference
timeFrame: At 3 months
measure: Measurement of hand circumference
timeFrame: At 6 months
measure: Measurement of hand circumference
timeFrame: At 1 year
measure: Saint-Antoine Pain Questionnaire (QDSA)
timeFrame: Day 0
measure: Saint-Antoine Pain Questionnaire (QDSA)
timeFrame: At 1,5 months
measure: Saint-Antoine Pain Questionnaire (QDSA)
timeFrame: At 3 months
measure: Saint-Antoine Pain Questionnaire (QDSA)
timeFrame: At 6 months
measure: Saint-Antoine Pain Questionnaire (QDSA)
timeFrame: At 1 year
measure: Cartographic assessment of pain
timeFrame: Day 0
measure: Cartographic assessment of pain
timeFrame: At 1,5 months
measure: Cartographic assessment of pain
timeFrame: At 3 months
measure: Cartographic assessment of pain
timeFrame: At 6 months
measure: Cartographic assessment of pain
timeFrame: At 1 year
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
timeFrame: Day 0
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
timeFrame: At 1,5 months
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
timeFrame: At 3 months
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
timeFrame: At 6 months
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
timeFrame: At 1 year
measure: Hospital Anxiety and Depression (HAD) Scale
timeFrame: Day 0
measure: Hospital Anxiety and Depression (HAD) Scale
timeFrame: At 1,5 months
measure: Hospital Anxiety and Depression (HAD) Scale
timeFrame: At 3 months
measure: Hospital Anxiety and Depression (HAD) Scale
timeFrame: At 6 months
measure: Hospital Anxiety and Depression (HAD) Scale
timeFrame: At 1 year
measure: The Short Form (36) Health Survey
timeFrame: Day 0
measure: The Short Form (36) Health Survey
timeFrame: At 1,5 months
measure: The Short Form (36) Health Survey
timeFrame: At 3 months
measure: The Short Form (36) Health Survey
timeFrame: At 6 months
measure: The Short Form (36) Health Survey
timeFrame: At 1 year
measure: Observance of wearing the compression garment
timeFrame: Every week for 3 months
measure: Tolerance of wearing the compression garment
timeFrame: Every week for 3 months
Other outcomes:
Locations:
city: Ploemeur
country: France
facility: CMRRF de Kerpape
state: Bretagne
Study officials:
affiliation: CMRRF de Kerpape
name: Vincent Detaille, Doctor
role: PRINCIPAL_INVESTIGATOR
References: