- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03361579
Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults (POLAP)
Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults - A Randomized Single Blinded Clinical Trail
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.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Basel Stadt
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Basel, Basel Stadt, Schweiz, 4031
- University Hospital Basel
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: 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
|
c.p. intervention description
|
Andet: 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.
|
c.p. intervention description
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pain response measured by the Area under the Pain Curve (AUPC)
Tidsramme: 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
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30 minutes after baseline until 100 minutes after baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Differences in pain response measured by the AUPC due to education
Tidsramme: 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.
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30 minutes after baseline until 100 minutes after baseline
|
hyperalgesia
Tidsramme: 100min
|
Hyperalgesia will be measured analogously to the NRS
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100min
|
Saliva cortisol concentration in μg/dL
Tidsramme: 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
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baseline until 100 min after baseline
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allodynia
Tidsramme: 100minutes
|
allodynia will be measured analogously to the NRS
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100minutes
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Wilhelm Ruppen, PD, Dep. Anesthesiology University Hospital Basel
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2017-01690
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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produkt fremstillet i og eksporteret fra U.S.A.
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