Psychogenic and Neurogenic Components in Patients With Psychogenic or Neuropathic Pruritus

NCT05024851 | Terminated

• 1 other identifier: PRURINEURO (29BRC21.0135)
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pruritus; Psychogenic Skin Disease; Neuropathic Pain; Itch

Keywords

Psychogenic Pruritus; Neuropathic Pruritus; Psychogenic Component; Neurogenic Component

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Patients with Psychogenic pruritus

Other: Questionnaires

Patients with Neuropathic Pruritus

Other: Questionnaires

Interventions

Questionnaires OTHER

Evaluation of the Psychogenic and Neurogenic Components using questionnaires

Patients with Neuropathic Pruritus; Patients with Psychogenic pruritus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Pruritus; Neuralgia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 27, 2021
• Study Start: August 25, 2021
• Primary Completion: July 8, 2022
• Study Completion: July 8, 2022
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning two years and ending five years following the publication
• 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.

Locations

FR (1)