Trial · NCT04251819
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Threshold | Baseline | Pain threshold refers to the intensity at which a stimulus is first perceived as painful. Heat stimuli will be delivered using a computer-controlled thermal stimulation system with a 30 millimeter X 30 millimeter probe. From a baseline of 32 degrees Celsius, the probe temperature will increase at a rate of .5 degrees Celsius/second until the participant responds by pressing a button on a handheld device. For heat pain threshold, participants will be instructed to press the button when the sensation "first becomes painful" Pain rating scores will be reflected in scores of 0-100, 0 being the least amount of pain and 100 being the most amount of pain. |
| Primary | Pain Threshold | 1.5 hours post-drug administration during session 2, occurs 7 ± 2 days after baseline visit | Pain threshold refers to the intensity at which a stimulus is first perceived as painful. Heat stimuli will be delivered using a computer-controlled thermal stimulation system with a 30 millimeter X 30 millimeter probe. From a baseline of 32 degrees Celsius, the probe temperature will increase at a rate of .5 degrees Celsius/second until the participant responds by pressing a button on a handheld device. For heat pain threshold, participants will be instructed to press the button when the sensation "first becomes painful" Pain rating scores will be reflected in scores of 0-100, 0 being the least amount of pain and 100 being the most amount of pain. |
| Primary | Pain Tolerance | Baseline | Pain tolerance refers to the maximum amount of pain produced by a stimulus that a person is able/willing to tolerate. Heat stimuli will again be delivered using the computer-controlled thermal stimulation system. From a baseline of 32 degrees Celsius, the probe temperature will increase at a rate of .5 degrees Celsius/second until the participant responds by pressing a button on a handheld device. For heat pain tolerance, participants will be instructed to press the button when they are "no longer willing to tolerate" the painful sensation. Pain rating scores will be reflected in scores of 0-100, 0 being the least amount of pain and 100 being the most amount of pain. |
| Primary | Pain Tolerance | 1.5 hours post-drug administration during session 2, occurs 7 ± 2 days after baseline visit | Pain tolerance refers to the maximum amount of pain produced by a stimulus that a person is able/willing to tolerate. Heat stimuli will again be delivered using the computer-controlled thermal stimulation system. From a baseline of 32 degrees Celsius, the probe temperature will increase at a rate of .5 degrees Celsius/second until the participant responds by pressing a button on a handheld device. For heat pain tolerance, participants will be instructed to press the button when they are "no longer willing to tolerate" the painful sensation. Pain rating scores will be reflected in scores of 0-100, 0 being the least amount of pain and 100 being the most amount of pain. |
| Primary | Temporal Summation of Pain | Baseline | Temporal summation of pain refers to a form of endogenous pain facilitation characterized by the perception of increased pain despite constant or even reduced peripheral afferent input. Temporal summation is presumed to be the psychophysical manifestation of wind-up. Wind-up is a phenomenon where repetitive stimulation of C primary afferents at rates greater than 0.3 Hertz produces a slowly increasing response of second-order neurons in the spinal cord. Pain rating scores will be reflected in scores of 0-100, 0 being the least amount of pain and 100 being the most amount of pain. |
| Primary | Temporal Summation of Pain | 1.5 hours post-drug administration during session 2, occurs 7 ± 2 days after baseline visit | Temporal summation of pain refers to a form of endogenous pain facilitation characterized by the perception of increased pain despite constant or even reduced peripheral afferent input. Temporal summation is presumed to be the psychophysical manifestation of wind-up. Wind-up is a phenomenon where repetitive stimulation of C primary afferents at rates greater than 0.3 Hertz produces a slowly increasing response of second-order neurons in the spinal cord. Pain rating scores will be reflected in scores of 0-100, 0 being the least amount of pain and 100 being the most amount of pain. |
| Primary | Conditioned Pain Modulation | Baseline | A routinely used quantitative sensory testing protocol for the measurement of endogenous pain inhibition is conditioned pain modulation, which refers to the reduction in pain from one stimulus (the test stimulus) produced by the application of a second pain stimulus at a remote body site (the conditioning stimulus). Conditioned pain modulation is believed to reflect the perceptual manifestation of diffuse noxious inhibitory controls, whereby ascending projections from one noxious stimulus activate supraspinal structures that trigger descending inhibitory projections to the dorsal horn. Pain rating scores for the test stimulus and the conditioning stimulus will be reflected in scores of 0-100, 0 being the least amount of pain and 100 being the most amount of pain. The conditioned pain modulation score is the difference between the two pain rating scores. |
| Primary | Conditioned Pain Modulation | 1.5 hours post-drug administration during session 2, occurs 7 ± 2 days after baseline visit | A routinely used quantitative sensory testing protocol for the measurement of endogenous pain inhibition is conditioned pain modulation, which refers to the reduction in pain from one stimulus (the test stimulus) produced by the application of a second pain stimulus at a remote body site (the conditioning stimulus). Conditioned pain modulation is believed to reflect the perceptual manifestation of diffuse noxious inhibitory controls, whereby ascending projections from one noxious stimulus activate supraspinal structures that trigger descending inhibitory projections to the dorsal horn. Pain rating scores for the test stimulus and the conditioning stimulus will be reflected in scores of 0-100, 0 being the least amount of pain and 100 being the most amount of pain. The conditioned pain modulation score is the difference between the two pain rating scores. |
| Primary | Suprathreshold Pain Response | Baseline | Ratings of pain in response to discrete stimuli with intensities above the pain threshold detection/ patients provide an intensity rating using any number of a 0-100 scale whereby 0=no pain and 100= the most intense pain imaginable |
| Primary | Suprathreshold Pain Response | 1.5 hours post-drug administration during session 2, occurs 7 ± 2 days after baseline visit | Ratings of pain in response to discrete stimuli with intensities above the pain threshold detection/ patients provide an intensity rating using any number of a 0-100 scale whereby 0=no pain and 100= the most intense pain imaginable |
| Secondary | Opioid Symptom Checklist | 30 minutes post-drug administration during session 2, occurs 7 ± 2 days after baseline visit | Measures the amount and intensity of side effects after being administered an opioid. The measure consists of 14 questions about potential opioid symptoms, and each the severity of the symptom is rated on a scale from 0 to 4, with 0 reflecting not at all feeling or being bothered by the symptom and 4 reflecting being severely bothered by the symptom. The score is the sum of the 14 responses. The minimum value is 0 and the maximum value is 56. |
| Secondary | 26-item Visual Analog Scale (VAS) | 30 minutes post-drug administration during session 2, occurs 7 ± 2 days after baseline visit | Measures subjective and physiological effects of a medication using mood states as well as questions about the dose of medication. The measure consists of 7 questions about potential drug effects, and each response is rated on a scale of 0 to 100, with 0 reflecting not at all feeling the effect and 100 reflecting very much feeling the effect. The score is the sum of the 7 responses. The minimum value is 0 and the maximum value is 700. |
| Secondary | Drug Effects Questionnaire-5 | 30 minutes post-drug administration during session 2, occurs 7 ± 2 days after baseline visit | Measures subjective experiences of a drug. The measure consists of 5 questions about the participant's experience of the drug effects, and each response is rated on a scale of 0 to 100, with 0 reflecting not at all having an experience and 100 reflecting extremely having that experience. The score is the sum of the 5 responses. The minimum value is 0 and the maximum value is 500. |
| Secondary | 26-item Visual Analog Scale ("Subjective Drug Effects") | 30 minutes post-drug administration during session 2, occurs 7 ± 2 days after baseline visit | This 26-item VAS measures subjective and physiological effects of a medication using mood states as well as questions about the dose of medication. The measure consists of 7 questions about potential drug effects, and each response is rated on a scale of 0 to 100, with 0 reflecting not at all feeling the effect and 100 reflecting very much feeling the effect. The score is the sum of the 7 responses. The minimum value is 0 and the maximum value is 700. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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