Background:
Much is known about how people perceive light touch, temperature, and pain. But less is known about how deep pressure is perceived. Deep pressure is an important part of many touch therapies, like massage therapy. Researchers want to learn more to help people with chronic pain and other disorders.
Objective:
To find out which sensory nerve fibers are involved in feeling the sensation of deep pressure.
Eligibility:
Healthy people ages 18 50 enrolled in study number 16-AT-0077
Design:
Participants will be screened under study number 16-AT-0077
Participants will have 1 visit that lasts about 2 hours.
Participants will have a brief medical interview. They will have a urine test.
Participants will have ischemic nerve block on 1 arm. A blood pressure cuff will be inflated until the arm is completely numb for up to an hour.
Participants will have tests to see how they perceive different sensations. They will rate gentle brushing on the arms. They will rate gentle pressure squeezing from a compression sleeve on the arms.
Participants will receive other sensations such as vibration, cool, warm, pinprick without piercing the skin, finger movement, and pressure. They will be asked to rate or respond to the sensations. They will be asked to rate any pain or discomfort from the nerve block on an ongoing basis.
Condition or disease | Intervention/treatment | Phase |
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Normal Physiology | Behavioral: Deep pressure block | Not Applicable |
Objective:
The sensory basis of non-painful deep pressure sensation is not known. We recently found that innocuous pressure sensation is eliminated in rare sensory neuronopathy patients with a specific loss of A-beta fibers, strongly suggesting that A-beta fibers underlie the ability to sense deep pressure. In addition, we and others have shown that deep pressure touch (observed in hugs and massage) frequently conveys a sense of pleasantness. The current study aims to examine the role of A-beta fibers in the perception of deep pressure touch including both its intensity and the pleasant affect it often elicits. This study constitutes the second study of the K99 phase of a K99/R00 grant application awarded to Dr. Laura Case by NCCIH.
Study Population:
Up to 24 healthy participants will be enrolled in the study with a goal of 12 completers. Participants will be invited based on previous screening and participation in our studies.
Design: Participants will undergo an ischemic-compression block. Sensory stimuli will be administered at frequent intervals to capture the loss of sensation related to A fibers as the block progresses. Before and after A-beta-associated sensations have been lost, the perception of deep pressure will be tested. Participants will rate the intensity and pleasantness of the pressure. Ratings of pain and discomfort will be collected throughout the study session.
Outcome measures: Primary outcome; Rating of intensity of deep pressure on the blocked arm before versus after loss of A-beta sensation, compared to ratings on the unblocked arm.
Secondary outcomes: 1) Rating of pleasantness of deep pressure on the blocked arm after loss of A-beta sensation, compared to ratings on the unblocked arm; 2) Ratings of intensity and pleasantness of gentle brushing on the blocked arm after loss of A-beta sensation, compared to ratings on the unblocked arm.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Sensory Afferents for Deep Pressure Sensation |
Actual Study Start Date : | June 20, 2019 |
Actual Primary Completion Date : | November 17, 2020 |
Actual Study Completion Date : | November 17, 2020 |
Arm | Intervention/treatment |
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Experimental: 1/Blocked Arm
Arm with applied deep pressure block
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Behavioral: Deep pressure block
Apply deep pressure block by using blood pressure cuff.
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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
All subjects must be:
EXCLUSION CRITERIA:
EXCLUSION CRITERIA FOR INDIVIDUAL STUDY SESSION:
United States, Maryland | |
National Institutes of Health Clinical Center | |
Bethesda, Maryland, United States, 20892 |
Principal Investigator: | Alexander T Chesler, Ph.D. | National Center for Complementary and Integrative Health (NCCIH) |
Tracking Information | |||||
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First Submitted Date ICMJE | May 3, 2019 | ||||
First Posted Date ICMJE | May 6, 2019 | ||||
Last Update Posted Date | December 17, 2020 | ||||
Actual Study Start Date ICMJE | June 20, 2019 | ||||
Actual Primary Completion Date | November 17, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Rating of intensity of deep pressure [ Time Frame: 1 visit ] Rating of intensity of deep pressure on the blocked arm before versus after loss of A-beta sensation, compared to ratings on the unblocked arm.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Sensory Afferents for Deep Pressure Sensation | ||||
Official Title ICMJE | Sensory Afferents for Deep Pressure Sensation | ||||
Brief Summary |
Background: Much is known about how people perceive light touch, temperature, and pain. But less is known about how deep pressure is perceived. Deep pressure is an important part of many touch therapies, like massage therapy. Researchers want to learn more to help people with chronic pain and other disorders. Objective: To find out which sensory nerve fibers are involved in feeling the sensation of deep pressure. Eligibility: Healthy people ages 18 50 enrolled in study number 16-AT-0077 Design: Participants will be screened under study number 16-AT-0077 Participants will have 1 visit that lasts about 2 hours. Participants will have a brief medical interview. They will have a urine test. Participants will have ischemic nerve block on 1 arm. A blood pressure cuff will be inflated until the arm is completely numb for up to an hour. Participants will have tests to see how they perceive different sensations. They will rate gentle brushing on the arms. They will rate gentle pressure squeezing from a compression sleeve on the arms. Participants will receive other sensations such as vibration, cool, warm, pinprick without piercing the skin, finger movement, and pressure. They will be asked to rate or respond to the sensations. They will be asked to rate any pain or discomfort from the nerve block on an ongoing basis. |
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Detailed Description |
Objective: The sensory basis of non-painful deep pressure sensation is not known. We recently found that innocuous pressure sensation is eliminated in rare sensory neuronopathy patients with a specific loss of A-beta fibers, strongly suggesting that A-beta fibers underlie the ability to sense deep pressure. In addition, we and others have shown that deep pressure touch (observed in hugs and massage) frequently conveys a sense of pleasantness. The current study aims to examine the role of A-beta fibers in the perception of deep pressure touch including both its intensity and the pleasant affect it often elicits. This study constitutes the second study of the K99 phase of a K99/R00 grant application awarded to Dr. Laura Case by NCCIH. Study Population: Up to 24 healthy participants will be enrolled in the study with a goal of 12 completers. Participants will be invited based on previous screening and participation in our studies. Design: Participants will undergo an ischemic-compression block. Sensory stimuli will be administered at frequent intervals to capture the loss of sensation related to A fibers as the block progresses. Before and after A-beta-associated sensations have been lost, the perception of deep pressure will be tested. Participants will rate the intensity and pleasantness of the pressure. Ratings of pain and discomfort will be collected throughout the study session. Outcome measures: Primary outcome; Rating of intensity of deep pressure on the blocked arm before versus after loss of A-beta sensation, compared to ratings on the unblocked arm. Secondary outcomes: 1) Rating of pleasantness of deep pressure on the blocked arm after loss of A-beta sensation, compared to ratings on the unblocked arm; 2) Ratings of intensity and pleasantness of gentle brushing on the blocked arm after loss of A-beta sensation, compared to ratings on the unblocked arm. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Normal Physiology | ||||
Intervention ICMJE | Behavioral: Deep pressure block
Apply deep pressure block by using blood pressure cuff.
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Study Arms ICMJE | Experimental: 1/Blocked Arm
Arm with applied deep pressure block
Intervention: Behavioral: Deep pressure block
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
4 | ||||
Original Estimated Enrollment ICMJE |
24 | ||||
Actual Study Completion Date ICMJE | November 17, 2020 | ||||
Actual Primary Completion Date | November 17, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
All subjects must be:
EXCLUSION CRITERIA:
EXCLUSION CRITERIA FOR INDIVIDUAL STUDY SESSION:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03937778 | ||||
Other Study ID Numbers ICMJE | 190089 19-AT-0089 |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | National Institutes of Health Clinical Center (CC) ( National Center for Complementary and Integrative Health (NCCIH) ) | ||||
Study Sponsor ICMJE | National Center for Complementary and Integrative Health (NCCIH) | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | National Institutes of Health Clinical Center (CC) | ||||
Verification Date | December 11, 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |