Sonographic Measurement of Intraneural Blood Flow in the Median Nerve

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome; Median Nerve Injury
• Interventions: Behavioral: Cooling; Behavioral: Heating; Behavioral: Exercising; Behavioral: Typing; Behavioral: Using a mouse; Behavioral: Cooking

• Registration Number: NCT05057754
• Lead Sponsor: University of Southern California

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-27
• Study Start: 2021-12-13
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Group	Cooking	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.
Experimental Group	Cooling	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.
Experimental Group	Exercising	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.
Experimental Group	Typing	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.
Experimental Group	Heating	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.
Experimental Group	Using a mouse	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.

Primary Outcome Measures

Name	Time	Method
Change in intraneural blood flow after intervention	Immediately prior to and after each 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.

Trial Locations

Locations (2)

USC; Musculoskeletal Sonography & Occupational Performance Laboratory; 🇺🇸 Los Angeles, California, United States

Ohio State University; School of Health and Rehabilitation Sciences; 🇺🇸 Columbus, Ohio, United States