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

Sponsor
Queen Elizabeth Hospital, Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT03909841
Collaborator
(none)
48
1
12
4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cambridge Neuropsychological Test Automated Battery (CANTAB)
  • Other: Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)

Study Design

Study Type:
Observational
Actual Enrollment :
48 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Neuropathic Pain in Elderly People With Diabetes: Impact on Quality of Life and Cognition
Actual Study Start Date :
Jun 1, 2017
Actual Primary Completion Date :
May 31, 2018
Actual Study Completion Date :
May 31, 2018

Arms and Interventions

Arm Intervention/Treatment
DM

DM without DPN (Diabetic Peripheral Neuropathy)

Behavioral: Cambridge Neuropsychological Test Automated Battery (CANTAB)
Cognition using Cambridge Neuropsychological Test Automated Battery (CANTAB)

Other: 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)

DPN

DM with DPN (Diabetic Peripheral Neuropathy)

Behavioral: Cambridge Neuropsychological Test Automated Battery (CANTAB)
Cognition using Cambridge Neuropsychological Test Automated Battery (CANTAB)

Other: 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)

DPN-P

DM with DPN-P (Diabetic Peripheral Neuropathic Pain)

Behavioral: Cambridge Neuropsychological Test Automated Battery (CANTAB)
Cognition using Cambridge Neuropsychological Test Automated Battery (CANTAB)

Other: 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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen Elizabeth Hospital Kowloon Hong Kong

Sponsors and Collaborators

  • Queen Elizabeth Hospital, Hong Kong

Investigators

  • Study Chair: Research Ethics Committee (Kowloon Central/ Kowloon East), Research Ethics Committee (Kowloon Central/ Kowloon East)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Woo Cheuk Wai, Physiotherapist, Queen Elizabeth Hospital, Hong Kong
ClinicalTrials.gov Identifier:
NCT03909841
Other Study ID Numbers:
  • KC/KE-17-0070/ER-1
First Posted:
Apr 10, 2019
Last Update Posted:
Apr 12, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2019