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Status unknownNCT03275233Updated Apr 22, 2019

Psychiatric Comorbidities in Patients With Painful Peripheral Neuropathy

An observational study in Painful Peripheral Neuropathy, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 66 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-22.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 66 Years
Sex
All
01

Study summary

Psychiatric comorbidities in patient with Painful Peripheral neuropathy

Read the 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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Conditions studied

  • Painful Peripheral Neuropathy
03

In context

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 66 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with painful peripheral neuropathy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Psychiatric comorbidities in diabetic patients with painful(symptomatic)peripheral neuropathy.

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

    Time frame: 6 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03275233
Lead sponsor
Assiut University
Responsible party
Andrew Ibrahim Farag (Principal Investigator, Assiut University) — Principal investigator
First posted
Sep 7, 2017
Start date
Sep 4, 2019 (estimated)
Primary completion
Jan 4, 2020 (estimated)
Completion
Jan 4, 2021 (estimated)
Last update
Apr 22, 2019

Study contacts

Noha Mohamed Abo Elfetoh, Professor
Contact
noha_ahmed_re@yahoo.com
01006800910

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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