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

NCT ID: NCT05034835

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2026-10-31

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.

Conditions

Complex Regional Pain Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

usual treatment with compression garments (CERECARE)

Intervention Type: 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.

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).

Group Type: OTHER

usual treatment without compression garments (CERECARE)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinique Mutualiste Lorient

UNKNOWN

Sponsor Role: collaborator

Fondation Rothschild Paris

OTHER

Sponsor Role: collaborator

Groupement des Hôpitaux de l'Institut Catholique de Lille

UNKNOWN

Sponsor Role: collaborator

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Detaille, Doctor

Role: PRINCIPAL_INVESTIGATOR

CMRRF de Kerpape

Locations

CMRRF de Kerpape

Ploemeur, Brittany Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Vincent Detaille, Doctor

Role: CONTACT

vincent.detaille@vyv3.fr

02 97 82 60 28 ext. +33

Marie-Caroline Delebecque, CRA

Role: CONTACT

kerpape.arc@vyv3.fr

02 97 82 62 93 ext. +33

Facility Contacts

Marie-Caroline Delebecque, CRA

Role: primary

kerpape.arc@vyv3.fr

02 97 82 62 93 ext. +33

Other Identifiers

2020-A00657-32

Identifier Type: -

Identifier Source: org_study_id