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

University Hospital Basel

Status: Completed

Conditions: Acute Pain

Treatments: Other: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT03361579

2017-01690

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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35 participants in 2 patient groups

Placebo education group

Other group

Description:

Prior to the intervention during the Placebo is given, the volunteer receives a detailed information about the effect and the strength of an open-label placebo. This education is performed via a slide show and a news report video. The important terms for Placebo analgesia: positive expectations, conditioning, communication are discussed

Treatment:

Other: Education

Placebo non education group

Other group

Description:

No detailed Information about open-label placebo prior to the intervention. The volunteer is told about the possible strength of the Placebo effect on pain directly before the application.

Treatment:

Other: Education