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

Completed

• Conditions: Diabetes Mellitus; Quality of Life; Diabetic Peripheral Neuropathic Pain; Diabetic Peripheral Neuropathy; Cognitive Impairment
• Interventions: Behavioral: Cambridge Neuropsychological Test Automated Battery (CANTAB); Other: Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)

• Registration Number: NCT03909841
• Lead Sponsor: Queen Elizabeth Hospital, Hong Kong

Brief Summary

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

Not available

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2019-04
• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-10
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DM	Cambridge Neuropsychological Test Automated Battery (CANTAB)	DM without DPN (Diabetic Peripheral Neuropathy)
DPN	Cambridge Neuropsychological Test Automated Battery (CANTAB)	DM with DPN (Diabetic Peripheral Neuropathy)
DM	Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)	DM without DPN (Diabetic Peripheral Neuropathy)
DPN	Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)	DM with DPN (Diabetic Peripheral Neuropathy)
DPN-P	Cambridge Neuropsychological Test Automated Battery (CANTAB)	DM with DPN-P (Diabetic Peripheral Neuropathic Pain)
DPN-P	Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)	DM with DPN-P (Diabetic Peripheral Neuropathic Pain)

Primary Outcome Measures

Name	Time	Method
Cognition	Day 1	Identifying cognitive affected domains by using Cambridge Neuropsychological Test Automated Battery (CANTAB) (Reaction Time : RTI, Spatial Working Memory : SWM and Executive Function : OTS)

Secondary Outcome Measures

Name	Time	Method
Quality of Life: The Chinese (Hong Kong) 12-item Short-Form Health Survey version 2	Day 1	Identifying Quality of Life affected domains by using The Chinese (Hong Kong) 12-item Short-Form Health Survey version 2

Trial Locations

Locations (1)

Queen Elizabeth Hospital; 🇭🇰 Kowloon, Hong Kong