Sensory Afferents for Deep Pressure Sensation

NCT03937778 | Completed Results

• 2 other identifiers: 19008919-AT-0089
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Normal Physiology

Keywords

Somatosensory

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  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

  From baseline to after loss of A-beta sensation, within one-hour session

Study Arms (1)

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.

Behavioral: Deep pressure block

Interventions

Deep pressure block BEHAVIORAL

Apply deep pressure block by using blood pressure cuff.

Tourniquet block to left upper arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Results Point of Contact

• Title: Chesler, Alexander
• Organization: National Center for Complementary and Integrative Health

alexander.chesler@nih.gov

+1 301 594 1049

Study Officials

• Alexander T Chesler, Ph.D.

  National Center for Complementary and Integrative Health (NCCIH)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 6, 2019
• Study Start: June 20, 2019
• Primary Completion: November 17, 2020
• Study Completion: November 17, 2020
• Last Updated: October 5, 2021
• Results First Posted: October 5, 2021

Record last verified: 2021-09

Locations

US (1)