PainNCT03709238
Pain Processing and Pain Reporting in Patients With Alzheimer's Disease
An observational study of Pain, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Thermal stimulation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 47 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Jan 2019to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Patients with Alzheimers disease 2. Healthy participants
Who may be able to join
- Mild to moderate patients with Alzheimers disease (group 1)
- Healthy participants ( group 2)
Who cannot join
- Chronic pain conditions
- Other medical, psychiatric or neurological disorders
- Use of pain-reliving medication 24 hours prior to testing
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Psychology and Behavioural Sciences
Aarhus, Central Jutland, 8000
About this study
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.
- Conditions
- Pain
- Being tested
- Thermal stimulation
- Keywords
- Pain, Alzheimers disease
- Medical subject headings
- Pain, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal stimulationBehavioural
Thermal stimulation
| Study group | Role | What they receive |
|---|---|---|
| Alzheimers diseased patients | Behavioral: Different thermal stimulation. Recording of facial expression during thermal stimulation. Receives: Behavioral: Thermal stimulation | |
| Healthy participants | Behavioral: Different thermal stimulation. Recording of facial expression during thermal stimulation. Receives: Behavioral: Thermal stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be tested on three different days. The numerical rating scale will be applied after each thermal stimulus for each test session.
Secondary outcomes (1)
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).
Measured: Participants will be video recorded on each of the three test days during testing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start3 Jan 2019
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709238
- Sponsor's protocol ID
- UAarhus_Susan
- Status last verified
- May 2021
- First submitted
- 3 Sep 2018
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Matthiesen ST, Sieg M, Andersen SS, Amanzio M, Finnerup NB, Jensen TS, Gottrup H, Vase L. Placebo analgesia and nocebo hyperalgesia in patients with Alzheimer disease and healthy participants. Pain. 2024 Feb 1;165(2):440-449. doi: 10.1097/j.pain.0000000000003035. Epub 2023 Sep 8.
PubMed 37703397
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Processing and Pain Reporting in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03709238
- Acronym / sponsor ID
- UAarhus_Susan
- Conditions
- Pain
- Keywords
- Pain, Alzheimers disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimers diseased patients | – | Behavioral: Thermal stimulationBehavioral: Different thermal stimulation. Recording of facial expression during thermal stimulation. |
| Healthy participants | – | Behavioral: Thermal stimulationBehavioral: Different thermal stimulation. Recording of facial expression during thermal stimulation. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with Alzheimers disease 2. Healthy participants
Key inclusion criteria (2 listed)
- Mild to moderate patients with Alzheimers disease (group 1)
- Healthy participants ( group 2)
Key exclusion criteria (3 listed)
- Chronic pain conditions
- Other medical, psychiatric or neurological disorders
- Use of pain-reliving medication 24 hours prior to testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal stimulationThermal stimulation | Behavioural | Alzheimers diseased patients, Healthy participants |
Primary outcome
Numerical rating scale (NRS)
Time frame: 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.
1 secondary outcome
Pain Assessment in persons with Impaired Cognition (PAIC)
Time frame: Participants will be video recorded on each of the three test days during testing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 37703397Matthiesen ST, Sieg M, Andersen SS, Amanzio M, Finnerup NB, Jensen TS, Gottrup H, Vase L. Placebo analgesia and nocebo hyperalgesia in patients with Alzheimer disease and healthy participants. Pain. 2024 Feb 1;165(2):440-449. doi: 10.1097/j.pain.0000000000003035. Epub 2023 Sep 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale (NRS) (time frame: Participants will be tested on three different days. The numerical rating scale will be applied after each thermal stimulus for each test session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03709238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.