Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-08 @ 12:44 PM
Study NCT ID:
NCT03275233
Status:
UNKNOWN
Last Update Posted:
2019-04-22
First Post:
2017-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychiatric Comorbidities in Patients With Painful Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2021-01-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-19', 'studyFirstSubmitDate': '2017-08-29', 'studyFirstSubmitQcDate': '2017-09-06', 'lastUpdatePostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychiatric comorbidities in diabetic patients with painful(symptomatic)peripheral neuropathy.', 'timeFrame': '6 month', 'description': '1- Pain assessment using visual analogue scale (VAS).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Painful Peripheral Neuropathy']}, 'descriptionModule': {'briefSummary': 'Psychiatric comorbidities in patient with Painful Peripheral neuropathy', 'detailedDescription': "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 .\n\nPatients 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.\n\nThe 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.\n\nIn 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) .\n\nRecently 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 ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '66 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with painful peripheral neuropathy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Any female or male diabetic patient is aged 18 years or above had diabetic peripheral neuropathy.\n2. patients must be able to swallow tables\n\nExclusion Criteria:\n\n1. Patients have other comorbid psychiatric disorders or psychological troubles that is not secondary to diabetic neuropathy according to clinical and psychiatric evaluation,\n2. Patients have any other causes of pain condition, or had skin conditions that are likely to confound the assessment of diabetic peripheral neuropathic pain.'}, 'identificationModule': {'nctId': 'NCT03275233', 'briefTitle': 'Psychiatric Comorbidities in Patients With Painful Peripheral Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Psychiatric Comorbidities in Patient With Painful Peripheral Neuropathy', 'orgStudyIdInfo': {'id': 'PCIPWPPN'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Noha Mohamed Abo Elfetoh, Professor', 'role': 'CONTACT', 'email': 'noha_ahmed_re@yahoo.com', 'phone': '01006800910'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andrew Ibrahim Farag', 'investigatorAffiliation': 'Assiut University'}}}}