NCT02322164

Psychophysical Correlates of Pain Reduction by Topical Analgesic Compounds

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: National Center for Complementary and Integrative Health (NCCIH) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Volunteers

Timeline

• Start date: 2014-12-19
• Primary completion: 2017-09-21
• Completion: 2018-07-02
• First posted: 2014-12-23
• Last updated: 2018-07-05

Locations

1 site across 1 country: United States