Chronic pain experience in adults with Down syndrome, with and without dementia, and the relationship with cognitive functioning.

Completed

• Conditions: 1) trisomy 21 or Down syndrome; 2) intellectual disabilities or mental retardation; 3) musculoskeletal disorders or impediment of joints; 10083624; 10023213; 10057167

• Registration Number: NL-OMON39082
• Lead Sponsor: Vrije Universiteit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 315

Inclusion Criteria

Control group:
*aged 18 years or older
*the group is matched with Down syndrome group on age and sex
*speaking and understanding the Dutch language;Patient group:
*Down syndrome
*calendar age 18 years or older
*speaking and understanding the Dutch language
*indications of possible dementia (in half of the subjects; see §4.4 Sample size calculation)
*estimated IQ 35 or higher
*sufficient understanding of the tests for pain experience and the cognitive tests;We are interested in musculoskeletal disorders (e.g. arthrosis, hip abnormalities or degenerative cervical spine instability), but this is not a request. We are both interested in persons that report pain and in persons that do not complain about pain (especially that last group is relevant). Thus, a presumption of pain is not a request.

Exclusion Criteria

Control group:
*diagnosis of intellectual disability
*age < 18 years
*diagnosis of dementia
*use of anticonvulsants or antipsychotics
*neurological conditions, e.g. tumors, strokes, or infarctions
*visual impairment to such a high degree that tests cannot be seen properly
*hearing loss to such a high degree that questions cannot be heard properly and sign language is known insufficiently
*major clinical psychopathology (e.g. major depression disorder);Pain medication and anti-inflammatory medication are not excluded, they will be statistically corrected. ;Patient group:
*moderately severe or severe dementia
*calendar age < 18 years
*estimated IQ<35 and/or incapacity to perform neuropsychological and pain measures
*use of anticonvulsants or antipsychotics
*presence of neurological conditions (tumors, hemorrhages, infarctions)
*visual impairment to such a high degree that tests cannot be seen properly
*hearing loss to such a high degree that questions cannot be heard properly and sign language is known insufficiently;Preferably, we exclude in the clinical group subjects with hypothyroidism, epilepsy, or major clinical psychopathology (e.g. major depression disorder). A low frequency or absence of complaining about pain is not an exclusion criterion! Pain medication and anti-inflammatory medication are not excluded, they will be statistically corrected.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pain experience; difference in pain experience between control group, Down<br /><br>syndrome, and Down syndrome with indications for dementia.<br /><br>Pain experience (both groups) consists of parameters for<br /><br>- intensity of pain<br /><br>- affect of pain<br /><br>- location of pain<br /><br>- tactile perception of pain<br /><br>- pain behaviour (observation of facial expressions and body movements)<br /><br><br /><br>Relationship between pain experience and cognitive functioning<br /><br>(neuropsychological test battery) in Down syndrome without and with indications<br /><br>for dementia.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Possible confounding variables that will be examined in both studies:<br /><br>- psychiatric comorbidity ([hetero]anamnesis and medical file)<br /><br>- physical comorbidity (medical file)<br /><br>- medication (medical file)<br /><br><br /><br>The usefulness of a computer test to answer questions about pain experience<br /><br>independently</p><br>