Neuropathic Pain in Elderly People With Diabetes: Impact on Quality of Life and Cognition

NCT ID: NCT03909841

Last Updated: 2019-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-05-31

Brief Summary

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This study was set out 1) Evaluate the impact of Diabetic Peripheral Neuropathy (DPN) and DPN-P (Diabetic Peripheral Neuropathic Pain) on the overall Quality of Life (QoL) in elderly with Diabetic Mellitus (DM) and 2) Evaluate the association between cognition impairments and DM in the elderly, and the contributions of DPN and/or DPN-P

Detailed Description

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Conditions

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Diabetes Mellitus Diabetic Peripheral Neuropathy Cognitive Impairment Quality of Life Diabetic Peripheral Neuropathic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DM

DM without DPN (Diabetic Peripheral Neuropathy)

Cambridge Neuropsychological Test Automated Battery (CANTAB)

Intervention Type BEHAVIORAL

Cognition using Cambridge Neuropsychological Test Automated Battery (CANTAB)

Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)

Intervention Type OTHER

Quality of Life using Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)

DPN

DM with DPN (Diabetic Peripheral Neuropathy)

Cambridge Neuropsychological Test Automated Battery (CANTAB)

Intervention Type BEHAVIORAL

Cognition using Cambridge Neuropsychological Test Automated Battery (CANTAB)

Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)

Intervention Type OTHER

Quality of Life using Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)

DPN-P

DM with DPN-P (Diabetic Peripheral Neuropathic Pain)

Cambridge Neuropsychological Test Automated Battery (CANTAB)

Intervention Type BEHAVIORAL

Cognition using Cambridge Neuropsychological Test Automated Battery (CANTAB)

Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)

Intervention Type OTHER

Quality of Life using Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)

Interventions

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Cambridge Neuropsychological Test Automated Battery (CANTAB)

Cognition using Cambridge Neuropsychological Test Automated Battery (CANTAB)

Intervention Type BEHAVIORAL

Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)

Quality of Life using Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged 50 or above
* Diagnosis of diabetes mellitus (Type 1 or Type 2)

Exclusion Criteria

* major psychiatric conditions
* recent cardiovascular events within the last six months
* blindness radiculopathy
* spinal cord injury, multiple sclerosis
* carpal tunnel syndrome
* trigeminal neuralgia
* Subjects who were incompetent in giving written consent
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen Elizabeth Hospital, Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Woo Cheuk Wai

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Research Ethics Committee (Kowloon Central/ Kowloon East)

Role: STUDY_CHAIR

Research Ethics Committee (Kowloon Central/ Kowloon East)

Locations

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Queen Elizabeth Hospital

Kowloon, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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KC/KE-17-0070/ER-1

Identifier Type: -

Identifier Source: org_study_id

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