Acute Pain
Conditions
Keywords
Placebo
Brief summary
Open Label Placebo application has been shown to be effective in treatment of chronic pain (low back pain) and disease like the irritable bowel Syndrome. Data about effects on acute pain are spare. The study investigates the effect of an open-label Placebo (substance without a medical active component) application on acute pain, evoked via a artificial pain model in healthy male volunteers. 32 healthy male volunteers are recruited.
Interventions
OTHEREducation
c.p. intervention description
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The investigator is blinded about the source of education a participant recieved prior to Placebo application. Investigator is blinded about during which Intervention the Placebo is applicated
Intervention model description
investigator blinded, cross over design
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy male volunteers (American Society of Anaesthesiologist's Class I or II) * Body mass index between 18 and 25kg/m2 * Able to understand the study and the NRS scale * Able to give informed consent
Exclusion criteria
* Recreational drug abuse * Regularly taking medication potentially interfere with pain sensation (analgesics, antihistamines and calcium and potassium channel blockers) * Neuropathy * Chronic pain * Neuromuscular or psychiatric disease * Known or suspected kidney or liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain response measured by the Area under the Pain Curve (AUPC) | 30 minutes after baseline until 100 minutes after baseline | Pain response measured by creating the Area under the Pain Curve (AUPC), using the numeric rating scale (NRS) from minute 30 to 100 during constant induced pain with electrical current at the forearm of the participant. Measuring of pain every 10 minutes from minute 30 to 100 (Minute 30,40,50,60,70,80,90, 100) in an experimental setting. Main comparison: The effect of open label placebo v.s. no treatment intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in pain response measured by the AUPC due to education | 30 minutes after baseline until 100 minutes after baseline | The pain response measured by the AUPC in participants received a detailed education about open label Placebo compared to those who received a short education direct prior to placebo administration. |
| hyperalgesia | 100min | Hyperalgesia will be measured analogously to the NRS |
| Saliva cortisol concentration in μg/dL | baseline until 100 min after baseline | Saliva concentration of cortisol, will be measured 4 times: at baseline, 30, 60 and 100 minutes during pain induction |
| allodynia | 100minutes | allodynia will be measured analogously to the NRS |
Countries
Switzerland
Outcome results
None listed