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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • usual treatment without compression garments (CERECARE)

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: With compression garmentsExperimental treatment 1 intervention
Group B: Without compression garmentsOther 1 intervention

Trial outcomes

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.

Time frame
up to 3 months

Secondary outcomes

1

Visual Analog Scale (VAS)

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.

Time frame
At 6 months
2

Visual Analog Scale (VAS)

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.

Time frame
At 1 year
3

Neuropathic Pain Symptom Inventory (NPSI)

It's a tool developed and validated in French, composed of 12 items. It provides an overall score and 5 sub-scores

Time frame
Day 0
4

Neuropathic Pain Symptom Inventory (NPSI)

It's a tool developed and validated in French, composed of 12 items. It provides an overall score and 5 sub-scores

Time frame
At 1,5 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Lead sponsor

Clinique Mutualiste Lorient

Collaborator

Fondation Rothschild Paris

Collaborator

Groupement des Hôpitaux de l'Institut Catholique de Lille

Collaborator