Analgesia
Conditions
Keywords
pain, placebo effects, analgesia, placebo analgesia, cold pressor test, breath metabolomics
Brief summary
This study is to analyze the breath metabolome before and after the administration of a placebo in an established experimental pain procedure in healthy subjects in order to investigate placebo effects, and whether they induce any measurable changes at the metabolic level.
Detailed description
Interrogation of the exhaled breath metabolome will be performed by using an objective method of measurement for placebo effects in pain analgesia, known as Cold Pressure Test (CPT). CPT reactions can be measured objectively by blood pressure spikes as well as changes in continuous heart rate monitoring.To this end, probands will be continuously connected to a Heartrate & Blood Pressure Monitor. First, baseline exhalation will be assessed. Then, the CPT is performed according to the 'CPT Guide' with subsequent post-pain exhalations analysis with or without self-administration of the placebo (NaCl nasal spray). After 15 minutes rest, probands will be submitted to a second post-pain exhalations set (+/- placebo). The process is completely non-invasive as the participant just exhales through a commercially available disposable bacterial/viral filter coupled to the ion source.
Interventions
Cold Pressor Test (CPT): apparatus for the task is a tank of water of temperature of 4 °C (+-0.5 °C), with instruction to immerse the hand until too uncomfortable to continue. A maximum time limit per immersion of 3-5 min is applied. Quantitative measurement can then be made of pain threshold (point first perceived as painful) and tolerance time.
OTHERPlacebo NaCl Nasal spray
placebo nasal spray containing NaCl solution
Sponsors
Swiss National Science Foundation
University Children's Hospital Basel
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
participants do not know its a placebo
Intervention model description
Single centered; national ,randomized, crossover, pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy female and male adult volunteers * German speaking, or good knowledge of the German language * Able to understand the study * Able to give informed consent
Exclusion criteria
* Regularly taking medication potentially interfering with pain sensation (analgesics, antihistamines and calcium and potassium channel blockers) * Current pregnancy * Daily smokers (as per WHO definition: A daily smoker is someone who smokes any tobacco product at least once a day.) * Neuropathy * Chronic pain * Neuromuscular or psychiatric disease * Known or suspected heart, kidney or liver disease * Hypertension (Systolic (mmHg) \>130, Diastolic (mmHg) \>80) * History of fainting or seizures * History of Frostbite * Current medications (psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in signal intensity of mass-to-charge ratio (m/z) of exhaled metabolites | 1 hour | The variable of primary interest is the variation of signal intensity of mass-to-charge ratio (m/z) of exhaled metabolites. |
Countries
Switzerland
Outcome results
None listed