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.

Overview

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.

Interventions

• Device 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.
• Other 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.

Primary outcome measures

• 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 [Time frame: up to 3 months]

Secondary outcome measures (12)

• Visual Analog Scale (VAS) [Time frame: At 6 months]
• Visual Analog Scale (VAS) [Time frame: At 1 year]
• Neuropathic Pain Symptom Inventory (NPSI) [Time frame: Day 0]
• Neuropathic Pain Symptom Inventory (NPSI) [Time frame: At 1,5 months]
• Neuropathic Pain Symptom Inventory (NPSI) [Time frame: At 3 months]
• Neuropathic Pain Symptom Inventory (NPSI) [Time frame: At 6 months]
• Neuropathic Pain Symptom Inventory (NPSI) [Time frame: At 1 year]
• Modification of analgesic drug treatment [Time frame: Day 0]
• Modification of analgesic drug treatment [Time frame: At 1,5 months]
• Modification of analgesic drug treatment [Time frame: At 3 months]
• Modification of analgesic drug treatment [Time frame: At 6 months]
• Modification of analgesic drug treatment [Time frame: At 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 1 center

• CMRRF de Kerpape — Ploemeur

Identifiers

NCT: NCT05034835 · 2020-A00657-32

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗