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OpenTrials
Completed

NCT Number: NCT03361579

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

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Other

c.p. intervention description

Primary outcomes

  1. Pain response measured by the Area under the Pain Curve (AUPC)

    Time frame: 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 outcomes

  1. Differences in pain response measured by the AUPC due to education

    Time frame: 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.

  2. hyperalgesia

    Time frame: 100min

    Hyperalgesia will be measured analogously to the NRS

  3. Saliva cortisol concentration in μg/dL

    Time frame: 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

  4. allodynia

    Time frame: 100minutes

    allodynia will be measured analogously to the NRS

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: POLAP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2017
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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