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Pain in adults with Down syndrome.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21264
Enrollment
315
Registered
2011-05-20
Start date
2012-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Down syndrome Cognition Dementia Pain Down syndrome Cognition Dementia

Interventions

Control group and clinical group: The pain perception in the subject will be studied using self-reported visual analogue scales, an observation list for pain behavior, and a test for tactile percepti

Sponsors

Performer: VU university, Department of Clinical Neuropsychology, The Netherlands. Main investigator: Nanda de Knegt (MSc.)Doctoral thesis supervisors: prof. dr. Scherder and prof. dr. Evenhuis. METC permission: submitted in May 2011, in progress.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Control group: N= 105 1. Aged 18 years or older; 2. One or several musculoskeletal disorders, e.g. arthrosis, hip abnormalities or degenerative cervical spine instability. Prevalence and type of musculoskeletal disorders in control group are matched with Down syndrome group, hence the musculoskeletal disorders are not always required; 3. Matched with Down syndrome group on age and sex. Patient group: N= 210 (N= 105 without dementia and N= 105 with dementia) 1. Down syndrome; 2. Calendar age 18 years or older; 3. Screening of dementia (in half of the subjects; N= 105); 4. Estimated IQ 35 or higher; 5. Sufficient understanding of the tests for pain experience and the cognitive tests; 6. We are interested in musculoskeletal disorders (e.g. arthrosis, hip abnormalities or degenerative cervical spine instability), but this is not a request; 7. We are both interested in persons that report pain and in persons that doe not complain about pain (expecially that last group is relevant). Thus, a presumption of pain is not a request.

Exclusion criteria

Exclusion criteria: Control group: 1. Diagnosis of intellectual disability; 2. Age < 18 years; 3. Diagnosis of dementia or incapacity to understand neuropsychological and pain measures; 4. Use of antiepileptic or antipsychotic; 5. Neurological conditions, e.g. tumors, strokes, or infarctions; 6. Visual impairment to such a high degree that tests cannot be seen properly; 7. Hearing loss to such a high degree that questions cannot be heard properly and sign language is known insufficiently; 8. Major clinical psychopathology (e.g. major depression disorder). Patient group: 1. Moderately severe or severe dementia; 2. Calendar age < 18 years; 3. Estimated IQ<35 and/or incapacity to perform neuropsychological and pain measures; 4. Use of anticonvulsants or antipsychotics; 5. Presence of neurological conditions (tumors, hemorrhages, infarctions); 6. Visual impairment to such a high degree that tests cannot be seen properly; 7. Hearing loss to such a high degree that questions cannot be heard properly and sign language is known insufficiently. Preferably, we exclude subjects with hypothyroidism, epilepsy, or major clinical psychopathology (e.g. major depression disorder). Pain medication and anti-inflammatory medication are not excluded, they will be statistically corrected.

Design outcomes

Primary

MeasureTime frame
The main study parameters are: 1. The difference in pain experience between the control group and Down syndrome group; 2. The difference in pain experience between Down syndrome adults without versus with indications for dementia; 3. The difference in the relationship between pain and cognitive functioning comparing Down syndrome adults without versus with dementia; 4. The difference in pain experience, cognitive functioning, and the relationship between pain experience and cognitive functioning comparing Down syndrome adults without versus with ApoE e4 allele.

Contacts

Public ContactN.C. Knegt, de

VU university Van der Boechorststraat 1 Department of Clinical Neuropsychology

nc.de.knegt@psy.vu.nl+31 (0)20 5980708

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)