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ID
Source
Brief title
Health condition
Healthy individuals
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome is the difference in CPM between the ‘standard’ protocol and the ‘home’ protocol.
Secondary outcome
Several questionnaires
Background summary
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.
Study objective
We hypothesize there is a difference in CPM between the protocols
Study design
Subjects will visit our facility on one occasion
Intervention
Standard CPM protocol vs LUMC CPM protocol
Inclusion criteria
1. Healthy according to medical history, physical examination and vital signs;
2. Age 18-40;
3. Able to give informed consent;
Exclusion criteria
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;
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9175 |
| Other | METC LDD : P20.084 |