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Clinical Trials/NCT02322164
NCT02322164CompletedNot Applicable

Psychophysical Correlates of Pain Reduction by Topical Analgesic Compounds

National Center for Complementary and Integrative Health (NCCIH)1 site in 1 country40 target enrollmentStarted: December 19, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Thermal sensory discrimination

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Thermal sensory discrimination

Time Frame: One time point

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Nih
Responsible Party
Sponsor

Study Sites (1)

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