Normal PhysiologyNCT03937778
Sensory Afferents for Deep Pressure Sensation
A study testing Deep pressure block in people with Normal Physiology, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Physiology
- What is being tested?
- Deep pressure block
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2019to 17 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All subjects must be:
- Between 18 and 50 years old.
- Fluent in English.
- Able to provide written informed consent.
- Enrolled in 16-AT-0077, Clinical and Scientific Assessment of Pain and Painful Disorders
Who cannot join
- Unable to comply with study procedures.
- Have used recreational drugs in the past 30 days.
- Pregnancy or breastfeeding.
- Congenital upper limb deficiency or amputation.
- Peripheral neuropathy, dermatological condition such as scars or burns, or has had a tattoo in the testing region within the previous four weeks that might influence cutaneous sensibility.
- Current chronic pain condition or has had chronic pain in the past year (painful condition lasting more than six months), including ongoing treatment with medications for neuropathic pain (e.g. gabapentin, tricyclic antidepressants, pregabalin, tramadol).
Show all 20Show fewer
- Major medical condition, such as kidney, liver, cardiovascular (including blood clots, hypertension, preexisting cardiac arrhythmia, lymphadenopathy), autonomic, pulmonary, or neurological problems (e.g., seizure disorder) or a chronic systemic disease (e.g., diabetes) or Raynaud s disease.
- Personal history or first-degree family history of blood clots or clotting and circulatory disorders
- History of a seizures or first-degree family member with a seizure disorder
- High (>140/90) or low (<90/60) blood pressure
- Current and untreated diagnosis of major depression, post-traumatic stress syndrome, bipolar disorder, psychosis, anxiety or panic disorder, alcohol or substance use disorders
- History of fainting with blood draws
- Any medical counter-indications to the nerve blocks.
- Participant s arm unable to fit in inflated arm blood pressure cuff
- Participant has taken any pain medication other than an over-the-counter NSAIDs or acetaminophen within the last month or for more than one month on a continual basis within last six months.
- Used topical pain-relieving creams in the testing area within 24 hours of testing or non-steroidal anti-inflammatory drugs (NSAIDS), (e.g. aspirin, ibuprofen, acetaminophen, or naproxen) within 3 days of testing
- Recent use of medications that increase risk of seizures (e.g. antidepressant Wellbutrin or antipsychotic Haldol)
- NIH employees who are subordinates, relatives, or co-workers of the investigators, or NCCIH DIR employees.
- Shows signs of alcohol withdrawal syndrome, or has behavioral signs of intoxication: will be excluded immediately and not have the possibility to reschedule their session.
- Used topical pain-relieving creams in the testing area (e.g. methylsalicylate, capsaicin) within 24 hours of testing or used non-steroidal anti-inflammatory drugs (NSAIDS, e.g. aspirin, ibuprofen), acetaminophen, or naproxen within 3 days of testing.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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 numb for up to an hour.
Participants will have tests to see how they perceive different sensations. They will rate gentle brushing on the hands and forearms. They will rate gentle pressure squeezing from a hand massager on the hands and forearms.
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.
Read the 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 National Center for Complementary and Integrative Health (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.
- Conditions
- Normal Physiology
- Being tested
- Deep pressure block
- Keywords
- Somatosensory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep pressure blockBehavioural
Apply deep pressure block by using blood pressure cuff.
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet block to left upper arm | Experimental | Participants underwent ~10 minutes of baseline testing followed by a tourniquet placement to left upper arm and inflated to 80-100 mmHG above systolic blood pressure. Participants repeatedly rated a variety of sensory stimuli after tourniquet was placed. Participants rated intensity and pleasantness of slow brushing and deep pressure on both hands/forearms at baseline and after loss of A-beta sensation. Receives: Behavioral: Deep pressure block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between Arms in the Change of Pressure Intensity From Baseline to After Loss of A-beta Sensation
Difference between left (blocked) and right (control) arms in the change from baseline to after loss of A-beta sensation from nerve block. Measurement of perceived pressure intensity was assessed using a visual analog scale ranging from "no sensation" (0) to "highest possible intensity" (100).
Measured: From baseline to after loss of A-beta sensation, within one-hour session
Secondary outcomes (3)
Difference Between Arms in the Change of Pressure Pleasantness From Baseline to After Loss of A-beta Sensation
Difference between left (blocked) and right (control) arms in the change from baseline to after loss of A-beta sensation from nerve block. Measurement of perceived pressure pleasantness was assessed using a visual analog scale ranging from "no sensation" (0) to "highest possible intensity" (100).
Measured: From baseline to after loss of A-beta sensation, within one-hour session
Difference Between Arms in the Change of Brushing Intensity From Baseline to After Loss of A-beta Sensation
Difference between left (blocked) and right (control) arms in the change from baseline to after loss of A-beta sensation from nerve block. Measurement of perceived brushing intensity was assessed using a visual analog scale ranging from "no sensation" (0) to "highest possible intensity" (100).
Measured: From baseline to after loss of A-beta sensation, within one-hour session
Difference Between Arms in the Change of Brushing Pleasantness From Baseline to After Loss of A-beta Sensation
Difference between left (blocked) and right (control) arms in the change from baseline to after loss of A-beta sensation from nerve block. Measurement of perceived brushing pleasantness was assessed using a visual analog scale ranging from "no sensation" (0) to "highest possible intensity" (100).
Measured: From baseline to after loss of A-beta sensation, within one-hour session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start20 Jun 2019
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Normal PhysiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Alexander T Chesler, Ph.D., Principal investigator, National Center for Complementary and Integrative Health (NCCIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937778
- Sponsor's protocol ID
- 190089
- Other IDs
- 19-AT-0089
- Status last verified
- Sep 2021
- First submitted
- 3 May 2019
- Last updated
- 5 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Afferents for Deep Pressure Sensation
- ClinicalTrials.gov ID
- NCT03937778
- Acronym / sponsor ID
- 190089
- Conditions
- Normal Physiology
- Keywords
- Somatosensory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Posted 5 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 numb for up to an hour.
Participants will have tests to see how they perceive different sensations. They will rate gentle brushing on the hands and forearms. They will rate gentle pressure squeezing from a hand massager on the hands and forearms.
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.
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 National Center for Complementary and Integrative Health (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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tourniquet block to left upper arm | Experimental | Behavioral: Deep pressure blockParticipants underwent ~10 minutes of baseline testing followed by a tourniquet placement to left upper arm and inflated to 80-100 mmHG above systolic blood pressure. Participants repeatedly rated a variety of sensory stimuli after tourniquet was placed. Participants rated intensity and pleasantness of slow brushing and deep pressure on both hands/forearms at baseline and after loss of A-beta sensation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between 18 and 50 years old.
- Fluent in English.
- Able to provide written informed consent.
- Enrolled in 16-AT-0077, Clinical and Scientific Assessment of Pain and Painful Disorders
Key exclusion criteria (20 listed)
- Unable to comply with study procedures.
- Have used recreational drugs in the past 30 days.
- Pregnancy or breastfeeding.
- Congenital upper limb deficiency or amputation.
- Peripheral neuropathy, dermatological condition such as scars or burns, or has had a tattoo in the testing region within the previous four weeks that might influence cutaneous sensibility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep pressure blockApply deep pressure block by using blood pressure cuff. | Behavioural | Tourniquet block to left upper arm |
Primary outcome
Difference Between Arms in the Change of Pressure Intensity From Baseline to After Loss of A-beta Sensation
Time frame: From baseline to after loss of A-beta sensation, within one-hour session
Difference between left (blocked) and right (control) arms in the change from baseline to after loss of A-beta sensation from nerve block. Measurement of perceived pressure intensity was assessed using a visual analog scale ranging from "no sensation" (0) to "highest possible intensity" (100).
3 secondary outcomes
Difference Between Arms in the Change of Pressure Pleasantness From Baseline to After Loss of A-beta Sensation
Time frame: From baseline to after loss of A-beta sensation, within one-hour session
Difference Between Arms in the Change of Brushing Intensity From Baseline to After Loss of A-beta Sensation
Time frame: From baseline to after loss of A-beta sensation, within one-hour session
Difference Between Arms in the Change of Brushing Pleasantness From Baseline to After Loss of A-beta Sensation
Time frame: From baseline to after loss of A-beta sensation, within one-hour session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander T Chesler, Ph.D. principal investigator
National Center for Complementary and Integrative Health (NCCIH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep pressure block in people with Normal Physiology, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference Between Arms in the Change of Pressure Intensity From Baseline to After Loss of A-beta Sensation (time frame: From baseline to after loss of A-beta sensation, within one-hour session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.