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

NCT ID: NCT03361579

Last Updated: 2018-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-11
• Study Completion Date: 2018-03-30

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.

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo education group

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

Group Type: OTHER

Education

Intervention Type: OTHER

c.p. intervention description

Placebo non education group

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.

Group Type: OTHER

Education

Intervention Type: OTHER

c.p. intervention description

Interventions

Education

c.p. intervention description

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilhelm Ruppen, PD

Role: STUDY_DIRECTOR

Dep. Anesthesiology University Hospital Basel

Locations

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-01690

Identifier Type: -

Identifier Source: org_study_id