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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

Tracking Information
First Submitted Date August 29, 2017
First Posted Date September 7, 2017
Last Update Posted Date April 22, 2019
Estimated Study Start Date September 4, 2019
Estimated Primary Completion Date January 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 6, 2017)
Psychiatric comorbidities in diabetic patients with painful(symptomatic)peripheral neuropathy. [ Time Frame: 6 month ]
1- Pain assessment using visual analogue scale (VAS).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Psychiatric Comorbidities in Patients With Painful Peripheral Neuropathy
Official Title Psychiatric Comorbidities in Patient With Painful Peripheral Neuropathy
Brief Summary Psychiatric comorbidities in patient with 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 .

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with painful peripheral neuropathy
Condition Painful Peripheral Neuropathy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 6, 2017)
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 4, 2021
Estimated Primary Completion Date January 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sexes Eligible for Study: All
Ages 18 Years to 66 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contact: Noha Mohamed Abo Elfetoh, Professor 01006800910
Listed Location Countries Not Provided
Removed Location Countries  
Administrative Information
NCT Number NCT03275233
Other Study ID Numbers PCIPWPPN
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Andrew Ibrahim Farag, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date January 2019