Impact of Compression Garments on Neuropathic-looking Pain in Patients With Complex Regional Pain Syndrome (CRPS) of the Upper Limbs.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
时间窗: 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.
次要结局
- Measurement of hand circumference(At 1 year)
- Saint-Antoine Pain Questionnaire (QDSA)(At 1 year)
- The Short Form (36) Health Survey(At 1 year)
- Modification of analgesic drug treatment(At 1 year)
- Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire(At 1 year)
- Neuropathic Pain Symptom Inventory (NPSI)(At 1 year)
- Cartographic assessment of pain(At 1 year)
- Measurement of muscle strength in both hands(At 1 year)
- Observance of wearing the compression garment(Every week for 3 months)
- Visual Analog Scale (VAS)(At 1 year)
- Measurement of range of motion(At 1 year)
- Hospital Anxiety and Depression (HAD) Scale(At 1 year)
- Tolerance of wearing the compression garment(Every week for 3 months)