Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults

Not Applicable

Completed

• Conditions: Acute Pain

• Registration Number: NCT03361579
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-11
• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-11-28
• Study First Posted: 2017-12-05
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Basel Stadt, Switzerland