Sonographic Measurement of Intraneural Blood Flow in the Median Nerve

NCT ID: NCT05057754

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-13
• Study Completion Date: 2022-05-30

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).

Conditions

Carpal Tunnel Syndrome; Median Nerve Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Experimental Group

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.

Group Type: EXPERIMENTAL

Cooling

Intervention Type: BEHAVIORAL

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

Heating

Intervention Type: BEHAVIORAL

A heat pack wrapped in a towel will be applied to participants' dominant hand for five minutes.

Exercising

Intervention Type: BEHAVIORAL

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.

Typing

Intervention Type: BEHAVIORAL

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.

Using a mouse

Intervention Type: BEHAVIORAL

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.

Cooking

Intervention Type: BEHAVIORAL

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.

Interventions

Cooling

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

Heating

A heat pack wrapped in a towel will be applied to participants' dominant hand for five minutes.

Intervention Type: BEHAVIORAL

Exercising

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

Typing

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

Using a mouse

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

Cooking

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Shawn Roll

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shawn C Roll, PhD

Role: STUDY_DIRECTOR

University of Southern California

Locations

USC; Musculoskeletal Sonography & Occupational Performance Laboratory

Los Angeles, California, United States

Ohio State University; School of Health and Rehabilitation Sciences

Columbus, Ohio, United States

Countries

United States

Other Identifiers

HS-21-04511

Identifier Type: -

Identifier Source: org_study_id