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Psychiatric Comorbidities in Patients With Painful Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03275233
Recruitment Status : Not yet recruiting
First Posted : September 7, 2017
Last Update Posted : April 22, 2019
Information provided by (Responsible Party):
Andrew Ibrahim Farag, Assiut University

Brief Summary:
Psychiatric comorbidities in patient with Painful Peripheral neuropathy

Condition or disease
Painful Peripheral Neuropathy

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 .

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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Psychiatric comorbidities in diabetic patients with painful(symptomatic)peripheral neuropathy. [ Time Frame: 6 month ]
    1- Pain assessment using visual analogue scale (VAS).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with painful peripheral neuropathy

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03275233

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Contact: Noha Mohamed Abo Elfetoh, Professor 01006800910

Sponsors and Collaborators
Assiut University

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Responsible Party: Andrew Ibrahim Farag, Principal Investigator, Assiut University Identifier: NCT03275233    
Other Study ID Numbers: PCIPWPPN
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms