We hypothesize there is a difference in CPM between the protocols
ID
Bron
Verkorte titel
Aandoening
Healthy individuals
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main study outcome is the difference in CPM between the ‘standard’ protocol and the ‘home’ protocol.
Achtergrond van het onderzoek
Rationale: Conditioned Pain Modulation (CPM) protocols differ across research sites all over the world. Data regarding the influence of the variation in protocols on the CPM outcome is lacking. To explore the factors that contribute to CPM variability we will conduct several CPM protocols in healthy volunteers in different laboratories over the world. The study will include two protocols, a standard protocol common to all participating laboratories, and a second protocol, the ‘home protocol’ used on each site. Each site will compare their own protocol to the standard protocol. Furthermore, all data will be transferred to the Rambam University in Israel for a overall analysis to explore factors that contribute to CPM variability.
Objective: To explore the factors that contribute to CPM variability in order to optimize testing protocols and minimize variability.
Study design: Observational study
Study population: 40 healthy volunteers
Intervention (if applicable): NA
Main study parameters/endpoints: The primary outcome is the difference in measured CPM between the standard and the home protocol.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for the patients is the time consumption while visiting our research facility. The CPM testing can induce short term effects e.g. skin redness or mild pain. Measuring CPM does not produce longer lasting effects.
Doel van het onderzoek
We hypothesize there is a difference in CPM between the protocols
Onderzoeksopzet
Subjects will visit our facility on one occasion
Onderzoeksproduct en/of interventie
Standard CPM protocol vs LUMC CPM protocol
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Healthy according to medical history, physical examination and vital signs;
2. Age 18-40;
3. Able to give informed consent;
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Presence of health issues including clinical pain of any kind in the previous 3 months;
2. Any use of pain medication;
3. Pregnancy or lactation;
4. Participation in another study at the same time;
5. Presence of in dept knowledge or experience of/in CPM testing or CPM study methods
6. Presence of Raynaud phenomenon;
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9175 |
| Ander register | METC LDD : P20.084 |