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

Acute Pain Clinical Trial

— POLAP  

Official title:

Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults - A Randomized Single Blinded Clinical Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03361579
• Other study ID #: 2017-01690
• Status: Completed
• Phase: N/A
• Start date: November 11, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: May 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain

Intervention

Other:
• Education
c.p. intervention description

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain response measured by the Area under the Pain Curve (AUPC)	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	30 minutes after baseline until 100 minutes after baseline
Secondary	Differences in pain response measured by the AUPC due to education	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.	30 minutes after baseline until 100 minutes after baseline
Secondary	hyperalgesia	Hyperalgesia will be measured analogously to the NRS	100min
Secondary	Saliva cortisol concentration in µg/dL	Saliva concentration of cortisol, will be measured 4 times: at baseline, 30, 60 and 100 minutes during pain induction	baseline until 100 min after baseline
Secondary	allodynia	allodynia will be measured analogously to the NRS	100minutes