Trial Outcomes & Findings for Sensory Afferents for Deep Pressure Sensation (NCT NCT03937778)

Last Updated: 2021-10-05

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

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

Results posted on

2021-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Tourniquet Block to Left Upper Arm 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.
Overall Study STARTED	7
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Tourniquet Block to Left Upper Arm 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.
Overall Study Withdrawal by Subject	1
Overall Study Unable to obtain loss of A-beta sensation prior to loss of C-fiber sensation	1

Baseline Characteristics

Sensory Afferents for Deep Pressure Sensation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tourniquet Block to Left Upper Arm n=7 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

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

Population: All participants who completed all phases of the testing session

Outcome measures

Outcome measures
Measure	Tourniquet Block to Left Upper Arm n=5 Participants 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.
Difference Between Arms in the Change of Pressure Intensity From Baseline to After Loss of A-beta Sensation	-25.0 Units on a scale Standard Deviation 19.65960325

SECONDARY outcome

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

Population: All participants who completed all phases of the testing 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 pleasantness was assessed using a visual analog scale ranging from "no sensation" (0) to "highest possible intensity" (100).

Outcome measures

Outcome measures
Measure	Tourniquet Block to Left Upper Arm n=5 Participants 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.
Difference Between Arms in the Change of Pressure Pleasantness From Baseline to After Loss of A-beta Sensation	-11.4 Units on a scale Standard Deviation 10.85357084

SECONDARY outcome

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

Population: All participants who completed all phases of the testing 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 brushing intensity was assessed using a visual analog scale ranging from "no sensation" (0) to "highest possible intensity" (100).

Outcome measures

Outcome measures
Measure	Tourniquet Block to Left Upper Arm n=5 Participants 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.
Difference Between Arms in the Change of Brushing Intensity From Baseline to After Loss of A-beta Sensation	-18.6 Units on a scale Standard Deviation 23.67065694

SECONDARY outcome

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

Population: All participants who completed all phases of the testing 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 brushing pleasantness was assessed using a visual analog scale ranging from "no sensation" (0) to "highest possible intensity" (100).

Outcome measures

Outcome measures
Measure	Tourniquet Block to Left Upper Arm n=5 Participants 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.
Difference Between Arms in the Change of Brushing Pleasantness From Baseline to After Loss of A-beta Sensation	-12.4 Units on a scale Standard Deviation 16.07171428

Adverse Events

Tourniquet Block to Left Upper Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chesler, Alexander

National Center for Complementary and Integrative Health

Phone: +1 301 594 1049

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place