Sonographic Measurement of Intraneural Blood Flow in the Median Nerve
Enhancing Sonographic Measurement of Intraneural Blood Flow in the Median Nerve
1 other identifier
interventional
20
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2021
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2021
CompletedFirst Posted
Study publicly available on registry
September 27, 2021
CompletedStudy Start
First participant enrolled
December 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedSeptember 28, 2023
September 1, 2023
6 months
September 15, 2021
September 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Immediately prior to and after each intervention
Study Arms (1)
Experimental Group
EXPERIMENTALA 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.
Interventions
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
A heat pack wrapped in a towel will be applied to participants' dominant hand for five minutes.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Aged 18 to 65
- English-speaking
- Ability to endure a moderate-intensity physical activity
- Ability to type without looking at the keyboard
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
USC; Musculoskeletal Sonography & Occupational Performance Laboratory
Los Angeles, California, 90033, United States
Ohio State University; School of Health and Rehabilitation Sciences
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shawn C Roll, PhD
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 15, 2021
First Posted
September 27, 2021
Study Start
December 13, 2021
Primary Completion
May 30, 2022
Study Completion
May 30, 2022
Last Updated
September 28, 2023
Record last verified: 2023-09