Psychophysical Correlates of Pain Reduction by Topical Analgesic Compounds
3. juli 2018 opdateret af: National Center for Complementary and Integrative Health (NCCIH)
Background:
- Researchers are studying a topical (skin) cream that reduces pain. This is called an analgesic cream. They want to try a new test to better measure how well it works. Heat will be applied to the participants arms and they will judge the intensity of the temperatures. Researchers will compare the pain reduction from this cream to other pain relief treatments.
Objective:
- To better measure the effects of a pain-relieving (analgesic) cream.
Eligibility:
- Healthy volunteers ages 18 50.
Design:
- There will be 2 study sessions.
Session 1 will be about 1.5 hours.
- Participants will be screened with physical exam and urine drug test. They will answer medical and psychological questions.
- Participants will have sensory testing.
- A moisturizer will be put on their arms. A heating device will be placed on their arms. It gives heat pulses of about 2 seconds each. Some are warm and some are very hot. Participants will say how strong each pulse is. They can move away if it gets painful.
- Then the pain-relieving cream will be put on one arm. The moisturizer will be put on the other. Participants will get more pulses and rate them. They will also get pairs of pulses and compare them.
- Some participants will return for session 2 for 1 hour. They will receive similar sensory testing as in session 1.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
This study uses a new testing design to evaluate pain reduction from a pain-relieving cream.
Sequences of heat stimuli will be applied to the participants arms and participants will be asked to judge the intensity of the temperatures they perceive.
There are two study sessions.
Session 1 involves eligibility screening and baseline sensory testing with and without the analgesic (pain-relieving) cream.
Session 2 involves more sensory testing with the analgesic cream.
The study population is 40 healthy volunteers aged 18 to 50.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
40
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Maryland
-
Bethesda, Maryland, Forenede Stater, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 50 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
- INCLUSION CRITERIA:
You may be eligible to participate in this research study if you are:
- Between 18 and 50 years old.
- Fluent in English.
- Able to understand the procedures described in this document and give your written consent.
EXCLUSION CRITERIA:
You may not be eligible to participate in this research study if you:
- Cannot complete the required procedures and tests in the study
- Used recreational drugs within the past six months
- Are in the third trimester of pregnancy
- Have a major medical condition or major medical history event that could affect touch and pain
- Have a medical condition that might affect touch and pain (e.g. Raynaud s Disease, peripheral neuropathy, or circulatory disorder)
- Have chronic pain or a history or chronic pain
- Have allergies to topical treatments
- Have a dermatological condition such as scars or burns, or have had a tattoo on your forearms within the previous four weeks that might influence touch or pain
- Had a recent or permanent injury of upper limbs or amputation or use a prosthetic limb
- Have participated in related NIH protocols (we will determine this)
- Used non-steroidal anti-inflammatory drugs (NSAIDS, e.g. aspirin, ibuprofen), acetaminophen, or sumatriptan within 3 days of testing (brand names include Advil, Tylenol, and Imitrex)
- Used narcotics (e.g. opioids, oxycodone) or pseudo narcotics (e.g. tramadol, tapentadol) within one week of testing (brand names include Percocet and Ultram)
- Use centrally acting medications like anticonvulsants (e.g. gabapentin, pregabalin), antidepressants (e.g. fluoxetine, duloxetine), antipsychotics (e.g. chlorpromazine, prochlorperazine), or anxiolytics (e.g. clonazepam, alprazolam) (Brand names include Neurontin, Lyrica, Prozac, Cymbalta, and Xanax)
- Use tobacco daily or used tobacco within 24 hours of testing
- Used topical pain-relieving creams in the testing area (e.g. methylsalicylate, capsaicin) within 24 hours of testing (Brand names include IcyHot and BenGay)
- Cannot schedule two sessions within two weeks
- Have consumed caffeine before 2 hours of testing
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Thermal sensory discrimination
Tidsramme: One time point
|
One time point
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Mary C Bushnell, Ph.D., National Center for Complementary and Integrative Health (NCCIH)
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
19. december 2014
Primær færdiggørelse (Faktiske)
21. september 2017
Studieafslutning (Faktiske)
2. juli 2018
Datoer for studieregistrering
Først indsendt
19. december 2014
Først indsendt, der opfyldte QC-kriterier
19. december 2014
Først opslået (Skøn)
23. december 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. juli 2018
Sidst verificeret
2. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 150048
- 15-AT-0048
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .