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

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Status: Enrolling

Conditions: Complex Regional Pain Syndromes

Treatments: Other: usual treatment without compression garments (CERECARE); Device: usual treatment with compression garments (CERECARE)

Study type: Interventional

Funder types: Other

Identifiers

NCT05034835

2020-A00657-32

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

With compression garments

Experimental group

Description:

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.

Treatment:

Device: usual treatment with compression garments (CERECARE)

Without compression garments

Other group

Description:

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).

Treatment:

Other: usual treatment without compression garments (CERECARE)