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

Completed

• Conditions: Pain
• Interventions: Behavioral: Thermal stimulation

• Registration Number: NCT03709238
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-17
• Study Start: 2019-01-03
• Status Verified: 2021-05
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Mild to moderate patients with Alzheimers disease (group 1)
• Healthy participants ( group 2)

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Exclusion Criteria

• Chronic pain conditions
• Other medical, psychiatric or neurological disorders
• Use of pain-reliving medication 24 hours prior to testing

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy participants	Thermal stimulation	Behavioral: Different thermal stimulation. Recording of facial expression during thermal stimulation.
Alzheimers diseased patients	Thermal stimulation	Behavioral: Different thermal stimulation. Recording of facial expression during thermal stimulation.

Primary Outcome Measures

Name	Time	Method
Numerical rating scale (NRS)	Participants will be tested on three different days. The numerical rating scale will be applied after each thermal stimulus for each test session.	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.

Secondary Outcome Measures

Name	Time	Method
Pain Assessment in persons with Impaired Cognition (PAIC)	Participants will be video recorded on each of the three test days during testing.	Video recordings will be analyzed with the PAIC scale from 0 (not at all) to 3 (great degree).

Trial Locations

Locations (1)

Department of Psychology and Behavioural Sciences; 🇩🇰 Aarhus, Midtjylland, Denmark