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Affective touch; reducing pain in Parkinson patients study 2

Affective touch; reducing pain in Parkinson patients study 2 - Affective touch; reducing pain in Parkinson patients study 2

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53643
Enrollment
34
Registered
2023-02-22
Start date
2024-03-15
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

Chronische pijn bij Parkinson Chronic pain in Parkinson patients

Interventions

Within this study we make use of a between-subject design. So participants will either receive three weeks of affective touch or non-affective touch (placebo).

Sponsors

Universiteit Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria: - Age >=18 - Diagnosed with PD, confirmed by Het Diakonessenhuis department of neurology or St. Antonius Hospital department of neurology - Pain associated with PD (musculoskeletal, dystonic, akathisia) and pain worsened by PD (i.e. (osteo)arthritis or other age-related pain conditions) - Pain must be present for at least 3 months, with clear impact on physical/psychological functioning, which must be assessed as at least moderate in intensity (>=4 points on the BPI).

Exclusion criteria

Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study: - Incapability of giving informed consent. To assess whether participants are able to give informed consent the token test will be used. The token test is used to assess language comprehension, if participants score below the cut-off score this may point to language comprehension problems which could alter their decision making and ability to provide informed consent, in which case participants are excluded from participation. - Incapability of interpreting questionnaires, the token test will also be used to assess the capability of interpreting the questionnaires. - Suffering from conditions that affect the ability to feel or process touch - Pain conditions that can also influence the perception and processing of touch; i.e. neuropathic pain, however if neuropathic pain does not alter the touch perception (allodynia) participant can still participate - A history of cerebral traumata or psychiatric disorders unrelated to PD (e.g., schizophrenic episodes)

Design outcomes

Primary

MeasureTime frame
The most important parameters are the changes in pain perception between the two types of stimulation measured with the questionnaires. We will do this by comparing the scores on the BPI for the AT condition and the non-AT touch condition.

Secondary

MeasureTime frame
Secondary outcomes are the differences in cognitive functioning and emotional well-being. We will do this by comparing the scores on the neuropsychological assessment pain and pleasantness questionnaires (SDMT, TMT, Rey Auditory verbal learning test, D-KEFS Color Word Interference Test, VAT, Digit Span Backward subtest van de WAIS-IV, Word Fluency, GDS-15, SCL-90 en 15D HRQoL Questionnaire, SHAPS) for the different types of stimulation and before and after treatment. In addition, we will look further into pain experience over the 3 weeks. This will be done by comparing the average BPI score per participant before, during (2x) and after treatment (total of 4 measurements).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026