Psychogenic and Neurogenic Components in Patients With Psychogenic or Neuropathic Pruritus : PRURINEURO, a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- DN4i
研究概览
简要总结
Scientific research on pruritus is in intensive development, with significant advances in understanding its pathophysiology. The causes of pruritus are very huge; they can be classified into different categories; we can find dermatological causes, systemic causes, neuropathic or neurological causes, psychogenic or even idiopathic causes.
The diagnosis of psychogenic pruritus is often over stated, when no cause is found; therefore, it is important to see what is really relieving from psychic so as not to over-diagnose and adopt a therapy more in line with the real problem of the patient. In daily practice, it seems to have a tendency to separate psychogenic and neurogenic etiologies in the diagnosis of neuropathic or psychogenic pruritus.
In the case of patients with psychogenic pruritus and neuropathic pruritus, no study has attempted to study the respective part of psychogenic and neurogenic components. Consequently, it would therefore be interesting to assess the areas of superposition and distinction of neuropathic and psychogenic pruritus.
The aim of this pilot study is to assess the psychogenic and neurogenic components of psychogenic pruritus and neuropathic pruritus in order to improve understanding of the mechanism and therefore their management.
The main objective of this study is to highlight the differences and the potential common characteristics between psychogenic and neuropathic pruritus in order to improve the differential diagnosis between these two pathologies.
The secondary objective of this study is to describe the psychogenic and neurogenic characteristics of psychogenic and neuropathic pruritus.
详细描述
PruriNeuro : Non-interventional single-center prospective study organized and practiced on humans for the development of medical knowledge, in which the data are obtained by validated questionnaires.
The duration of participation is estimated at 1 hour.
Questionnaires used :
- Critères diagnostiques du prurit psychogène (Diagnosis criteria of functional itch disorder or psychogenic pruritus, from the French psychodermatology group)
- NP5 questionnaire
- Questionnaire de Brest
- HADS
- TAS-20
- DN4i
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Major (> 18 years old)
- •Diagnosis of psychogenic pruritus or neuropathic pruritus made in consultation, in day hospital or in hospital, within the dermatology department at the CHRU de Brest
- •Able to understand and agree to sign the information and non-opposition notice
- •No opposition of the patient
排除标准
- •Patient under legal protection (guardianship, curatorship)
- •Minor (<18 years old)
- •Acute or chronic condition which could limit the patient's ability to the study's participation
- •Inability to understand and sign the information and non-opposition notice
- •Refusal to give no opposition
结局指标
主要结局
DN4i
时间窗: at the enrollment
score equal to or greater than 3 : in favor of neuropathic pruritus
Questionnaire de Brest
时间窗: at the enrollment
Qualitative assessment of pruritus, specifying the chronology, location, intensity, characteristics and effect on daily activities of the itching induced by pruritus
NP5
时间窗: at the enrollment
A score of two criteria out of five is optimal to discriminate Neuropathic pruritus (NP) from Non-NP
TAS-20
时间窗: at the enrollment
The TAS-20 is a self-report scale that is comprised of 20 items. Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree. There are 5 items that are negatively keyed (items 4, 5, 10, 18 and 19). The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
Diagnosis criteria of functional itch disorder or psychogenic pruritus, from the French psychodermatology group
时间窗: at the enrollment
three compulsory criteria; Three additional criteria from seven items should also be present
HADS (Hospital Anxiety and Depression Scale)
时间窗: at the enrollment
Total score for Depression or Anxiety 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
次要结局
未报告次要终点