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

NCT05034835 | Recruiting

• 1 other identifier: 2020-A00657-32
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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

  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 Outcomes (54)

• Visual Analog Scale (VAS)

  At 6 months

• Visual Analog Scale (VAS)

  At 1 year

• Neuropathic Pain Symptom Inventory (NPSI)

  Day 0

• Neuropathic Pain Symptom Inventory (NPSI)

  At 1,5 months

• Neuropathic Pain Symptom Inventory (NPSI)

  At 3 months

Study Arms (2)

With compression garments

EXPERIMENTAL

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.

Device: usual treatment with compression garments (CERECARE)

Without compression garments

OTHER

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).

Other: usual treatment without compression garments (CERECARE)

Interventions

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.

With compression garments

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.

Without compression garments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape: lead
• Clinique Mutualiste Lorient: collaborator
• Fondation Rothschild Paris: collaborator
• Groupement des Hôpitaux de l'Institut Catholique de Lille: collaborator

Study Sites (1)

CMRRF de Kerpape

Ploemeur, Brittany Region, 56270, France

RECRUITING

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Vincent Detaille, Doctor

  CMRRF de Kerpape

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Detaille, Doctor

CONTACT

02 97 82 60 28; vincent.detaille@vyv3.fr

Marie-Caroline Delebecque, CRA

CONTACT

02 97 82 62 93; kerpape.arc@vyv3.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 5, 2021
• Study Start: October 12, 2021
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)