Pain Processing and Pain Reporting in Patients With Alzheimer's Disease

Pain Clinical Trial

Official title:

Pain Processing and Pain Reporting in Patients With Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03709238
• Other study ID #: UAarhus_Susan
• Status: Completed
• Start date: January 3, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: May 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study investigates pain processing and pain reporting in patients with Alzheimers disease compared to healthy participants.

Employing a within-subject design, the study includes patients with Alzheimers disease and healthy participants that are exposed to thermal stimuli. During the test session the facial expressions of the participant are video recorded.

By repeating this on separate test days, the involvement of pain relief and pain increase is investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Mild to moderate patients with Alzheimers disease (group 1)

• Healthy participants ( group 2)

Exclusion Criteria:

• Chronic pain conditions

• Other medical, psychiatric or neurological disorders

• Use of pain-reliving medication 24 hours prior to testing

Related Conditions & MeSH terms

• Alzheimer Disease
• Pain

Intervention

Behavioral:
• Thermal stimulation
Thermal stimulation

Locations

Country	Name	City	State
Denmark	Department of Psychology and Behavioural Sciences	Aarhus	Midtjylland

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical rating scale (NRS)	Acute pain assessed on numerical rating scale from 0 (no pain experience) to 10 (worst pain), examining pain intensity. The participant will provide a number on the scale which reflects their pain intensity.	Participants will be tested on three different days. The numerical rating scale will be applied after each thermal stimulus for each test session.
Secondary	Pain Assessment in persons with Impaired Cognition (PAIC)	Video recordings will be analyzed with the PAIC scale from 0 (not at all) to 3 (great degree).	Participants will be video recorded on each of the three test days during testing.