Psychogenic and Neurogenic Components in Patients With Psychogenic or Neuropathic Pruritus (PRURINEURO)

Psychogenic and Neurogenic Components in Patients With Psychogenic or Neuropathic Pruritus : PRURINEURO, a Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Neuropathic Pain; Pruritus; Itch; Psychogenic Skin Disease
• Intervention / Treatment: Other: Questionnaires

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with neuropathic or psychogenic pruritus consulting in the dermatology department of the CHRU de Brest.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Psychogenic pruritus	Other: Questionnaires; Evaluation of the Psychogenic and Neurogenic Components using questionnaires
Patients with Neuropathic Pruritus	Other: Questionnaires; Evaluation of the Psychogenic and Neurogenic Components using questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire de Brest	Qualitative assessment of pruritus, specifying the chronology, location, intensity, characteristics and effect on daily activities of the itching induced by pruritus	at the enrollment
HADS (Hospital Anxiety and Depression Scale)	Total score for Depression or Anxiety 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)	at the enrollment
NP5	A score of two criteria out of five is optimal to discriminate Neuropathic pruritus (NP) from Non-NP	at the enrollment
TAS-20	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.	at the enrollment
DN4i	score equal to or greater than 3 : in favor of neuropathic pruritus	at the enrollment
Diagnosis criteria of functional itch disorder or psychogenic pruritus, from the French psychodermatology group	three compulsory criteria; Three additional criteria from seven items should also be present	at the enrollment

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2021
• Primary Completion (Actual): July 8, 2022
• Study Completion (Actual): July 8, 2022

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Psychogenic Pruritus; Neuropathic Pruritus; Psychogenic Component; Neurogenic Component
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Skin Manifestations; Neuralgia; Pruritus; Skin Diseases
• Other Study ID Numbers: PRURINEURO (29BRC21.0135)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning two years and ending five years following the publication
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No