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Touch; reducing pain in Parkinson patients study 1

Touch; reducing pain in Parkinson patients study 1 - Touch; reducing pain in Parkinson patients study 1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49609
Enrollment
35
Registered
2020-04-30
Start date
2020-09-21
Completion date
Unknown
Last updated
2025-08-18

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 within-subject design. So patients will receive affective touch and non-affective touch (placebo).

Sponsors

Universiteit Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Age >=18 -Diagnosed with PD, confirmed by ParkinsonNEXT and if necessary; i.e. inclusion criteria are unclear or the experimenter still has some questions, the experiment will check with the patient*s general practitioner. -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 an 11-point Likert pain scale). -Written informed consent (to assess whether participants are able to give informed consent the MoCa will be used prior to intervention).

Exclusion criteria

Exclusion criteria: -Incapability of giving informed consent -Incapability of interpreting questionnaires The following criteria will be checked for and confirmed by ParkinsonNEXT and if necessary; i.e. inclusion criteria are unclear or the experimenter still has some questions, the experiment will check with the patient*s general practitioner: -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; -A history of cerebral traumata or psychiatric disorders unrelated to PD (e.g., schizophrenic episodes) -Currently suffering from a mood disorder (e.g. depression or anxiety disorder)

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 Faces Pain Scale and CAS Pain Scale for the non-stimulation condition, AT condition and the non-AT condition.

Secondary

MeasureTime frame
Secondary outcomes are the pleasantness of the two types of stimulation measured with the questionnaires. Previous studies show that AT is rated significantly more pleasant than non-AT. Therefore to replicate this effect, we will measure pleasantness as well. This will be done by comparing the scores on the PANAS and VAS pleasantness for the AT condition and the non-AT condition. In addition, we will look for differences over time for the different timepoints (morning, afternoon and evening) and assess the stimulation duration (0,5,10,15 minutes), to see how long stimulation is necessary and what the preferences of the participants are. We will do this by comparing the scores on the pain and pleasantness questionnaires (Faces Pain Scale, CAS Pain Scale and VAS pleasantness) for the different timepoints in the AT and non-AT condition.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)