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Sonographic Measurement of Intraneural Blood Flow in the Median Nerve

Primary Purpose

Carpal Tunnel Syndrome, Median Nerve Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cooling
Heating
Exercising
Typing
Using a mouse
Cooking
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Carpal Tunnel Syndrome focused on measuring intraneural blood flow

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 18 to 65
  • English-speaking
  • Ability to endure a moderate-intensity physical activity
  • Ability to type without looking at the keyboard

Exclusion Criteria:

  • Pain, tingling, or numbness in the hand or wrist region within the past week
  • History of corticoid injection in the upper extremity
  • History of surgery in the wrist region
  • Carpal tunnel syndrome
  • Amyotrophic lateral sclerosis
  • Diabetes
  • Hypothyroidism
  • Pregnant
  • Positive Phalen's test
  • Persistent median artery within wrist region
  • Bifid median nerve

Sites / Locations

  • USC; Musculoskeletal Sonography & Occupational Performance Laboratory
  • Ohio State University; School of Health and Rehabilitation Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Group

Arm Description

A total of 50 participants are estimated to be recruited, each completing six conditions in the following order: 1) wrist cooling, 2) wrist heating, 3) exercising, 4) typing, 5) using a mouse, 6) cooking, with an observation of intraneural blood flow assessed with Doppler sonography before and after each condition.

Outcomes

Primary Outcome Measures

Change in intraneural blood flow after intervention
Doppler ultrasound images will be repeatedly collected to obtain the primary outcome measure for this study, intraneural blood flow. After identifying the course of the median nerve in the longitudinal plane (I.e., the sagittal plane), intraneural blood flow at the level of carpal tunnel measured as the peak systolic velocity of the identified blood flow signal will be observed and collected.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2021
Last Updated
September 25, 2023
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT05057754
Brief Title
Sonographic Measurement of Intraneural Blood Flow in the Median Nerve
Official Title
Enhancing Sonographic Measurement of Intraneural Blood Flow in the Median Nerve
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Carpal tunnel syndrome (CTS) is the most common nerve compression disease and the most expensive upper-extremity work-related musculoskeletal disorder, affecting approximately 10 million people in the US. To understand the clear etiology and mechanism of carpal tunnel syndrome, the measurement of median nerve intraneural blood flow needs to be further scrutinized as the common fluctuating physiological conditions and functional hand activities might contribute to the fluctuation of the measurement and serve as measurement error. This study aims to examine how intraneural blood flow within the median nerve is affected by physiological factors (i.e., body temperature and blood pressure) and functional hand activities (i.e., typing, using a mouse, and cooking).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Median Nerve Injury
Keywords
intraneural blood flow

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
A total of 50 participants are estimated to be recruited, each completing six conditions in the following order: 1) wrist cooling, 2) wrist heating, 3) exercising, 4) typing, 5) using a mouse, 6) cooking, with an observation of intraneural blood flow assessed with Doppler sonography before and after each condition.
Intervention Type
Behavioral
Intervention Name(s)
Cooling
Intervention Description
Participants' dominant hand and wrist will be immersed in cool water (20°C) for five minutes. The cool water will be kept to around 20°C (19 - 21°C) by frequently checking the temperature and corrected when it rises to 20.5°C
Intervention Type
Behavioral
Intervention Name(s)
Heating
Intervention Description
A heat pack wrapped in a towel will be applied to participants' dominant hand for five minutes.
Intervention Type
Behavioral
Intervention Name(s)
Exercising
Intervention Description
Participants will be asked to participate in moderate-intensity physical activities to induce an increase in blood pressure. The physical activity will be two sets of 30 jumping jacks, followed by 15 squats. Participants are allowed to rest for 20 seconds between the two sets.
Intervention Type
Behavioral
Intervention Name(s)
Typing
Intervention Description
All participants will be asked to perform a typing task with a standard wired keyboard. All subjects will be asked to type for five minutes.
Intervention Type
Behavioral
Intervention Name(s)
Using a mouse
Intervention Description
Participants will be asked to draw as many lower-case alphabet characters from "a" to "z" as possible using a standardized scroll mouse for five minutes in the Windows Microsoft Paint software.
Intervention Type
Behavioral
Intervention Name(s)
Cooking
Intervention Description
Participants will be asked to participate in a cooking trial following a prespecified cooking recipe of Rice Krispy Treat. he participant will be asked to follow the procedures as follows: (1) cut and put wax paper in the pan; (2) cut butter into 4 pieces; (3) place butter in a pot over a portable stove and stir until the butter is completely melted; (4) add four oz of marshmallows and stir until melted; (5) add cereal and the rest of marshmallows and stir until all ingredients are combined (6) transfer the ingredients to the pan and use a silicone spatula to pat the ingredients evenly into pan.
Primary Outcome Measure Information:
Title
Change in intraneural blood flow after intervention
Description
Doppler ultrasound images will be repeatedly collected to obtain the primary outcome measure for this study, intraneural blood flow. After identifying the course of the median nerve in the longitudinal plane (I.e., the sagittal plane), intraneural blood flow at the level of carpal tunnel measured as the peak systolic velocity of the identified blood flow signal will be observed and collected.
Time Frame
Immediately prior to and after each intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18 to 65 English-speaking Ability to endure a moderate-intensity physical activity Ability to type without looking at the keyboard Exclusion Criteria: Pain, tingling, or numbness in the hand or wrist region within the past week History of corticoid injection in the upper extremity History of surgery in the wrist region Carpal tunnel syndrome Amyotrophic lateral sclerosis Diabetes Hypothyroidism Pregnant Positive Phalen's test Persistent median artery within wrist region Bifid median nerve
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn C Roll, PhD
Organizational Affiliation
University of Southern California
Official's Role
Study Director
Facility Information:
Facility Name
USC; Musculoskeletal Sonography & Occupational Performance Laboratory
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Ohio State University; School of Health and Rehabilitation Sciences
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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Sonographic Measurement of Intraneural Blood Flow in the Median Nerve

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