Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03275233
Other study ID # PCIPWPPN
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 4, 2019
Est. completion date January 4, 2021

Study information

Verified date January 2019
Source Assiut University
Contact Noha Mohamed Abo Elfetoh, Professor
Phone 01006800910
Email noha_ahmed_re@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Psychiatric comorbidities in patient with Painful Peripheral neuropathy


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date January 4, 2021
Est. primary completion date January 4, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 66 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Psychiatric comorbidities in diabetic patients with painful(symptomatic)peripheral neuropathy. 1- Pain assessment using visual analogue scale (VAS). 6 month
See also
  Status Clinical Trial Phase
Unknown status NCT02243475 - Probing the Role of Sodium Channels in Painful Neuropathies N/A