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Recruiting Not applicable

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

NCT05034835 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-10-12
Last updated
2025-10-06

Condition(s) studied

Complex Regional Pain Syndromes

Investigational drug(s) / intervention(s)

usual treatment with compression garments (CERECARE)usual treatment without compression garments (CERECARE)

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.

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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 — up to 3 months
    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.

Trial sites (1)

FacilityCityRegionStatus
CMRRF de Kerpape Ploemeur Brittany Region Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05034835 on ClinicalTrials.gov ↗ ← All trials in France