Psychiatric Comorbidities in Patients With Painful Peripheral Neuropathy

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03275233
Collaborator
(none)
40
16

Study Details

Study Description

Brief Summary

Psychiatric comorbidities in patient with Painful Peripheral neuropathy

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Neuropathic pain has been redefined by the International Association for the Study of Pain, as'' pain caused by a lesion or disease of somatosensory system''.Diabetic peripheral neuropathy is the result of nerve damage in the toes, feet, and hands . Approximately 50% of those diabetic peripheral neuropathy have neuropathic pain .

    Patients with persistent neuropathic pain experience work disability and activity limitation, with a substantial impact on their social functioning. As any chronic pain state comorbid depression, anxiety and sleep disturbance are common occurring in up to one half of those with painful neuropathy.

    The relationship between chronic pain and cognitive function has not been adequately studied and little is known about cognitive functioning in neuropathic conditions. This may be because the clinicians pay more attention to psychiatric comorbidities, such as depression and anxiety.Although chronic pain associated with cognitive deficits may impact on everyday behaviour and interfere with emotional decision-making tasks.

    In a cross-sectional survey at the Mayo clinic, the prevalence of clinician-diagnosed symptomatic or painful diabetic peripheral neuropathy was 13-15% out of 78% of those with any type of diabetic peripheral neuropathy . Many patients with diabetic peripheral neuropathy experience neuropathic pain, typically characterized as burning, electric, sharp and shooting which initially starts in both feet and may progress to involve calves, fingers, and hands (stocking and glove pattern) .

    Recently it has been demonstrated an association between diabetes , diabetes complication and impairment of mental health and particular emphasis has been placed on the association between painful diabetic sensory neuropathy with depression .

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Psychiatric Comorbidities in Patient With Painful Peripheral Neuropathy
    Anticipated Study Start Date :
    Sep 4, 2019
    Anticipated Primary Completion Date :
    Jan 4, 2020
    Anticipated Study Completion Date :
    Jan 4, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Psychiatric comorbidities in diabetic patients with painful(symptomatic)peripheral neuropathy. [6 month]

      1- Pain assessment using visual analogue scale (VAS).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 66 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Any female or male diabetic patient is aged 18 years or above had diabetic peripheral neuropathy.

    2. patients must be able to swallow tables

    Exclusion Criteria:
    1. Patients have other comorbid psychiatric disorders or psychological troubles that is not secondary to diabetic neuropathy according to clinical and psychiatric evaluation,

    2. Patients have any other causes of pain condition, or had skin conditions that are likely to confound the assessment of diabetic peripheral neuropathic pain.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrew Ibrahim Farag, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03275233
    Other Study ID Numbers:
    • PCIPWPPN
    First Posted:
    Sep 7, 2017
    Last Update Posted:
    Apr 22, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 22, 2019