Touch; reducing pain in Parkinson patients study 1

Completed

• Conditions: Chronische pijn bij Parkinson; Chronic pain in Parkinson patients; 10042258

• Registration Number: NL-OMON49609
• Lead Sponsor: niversiteit Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-12-19
• Results First Posted: 2024-08-01
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

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

-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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The most important parameters are the changes in pain perception between the<br /><br>two types of stimulation measured with the questionnaires. We will do this by<br /><br>comparing the scores on the Faces Pain Scale and CAS Pain Scale for the<br /><br>non-stimulation condition, AT condition and the non-AT condition. </p><br>

Secondary Outcome Measures

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