Psychophysical Correlates of Pain Reduction by Topical Analgesic Compounds

Completed

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT02322164

Run by

National Center for Complementary and Integrative Health (NCCIH)

People needed

40

Starts

2014-12-19

Expected to finish

2018-07-02

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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