NCT05057754

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

December 13, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

September 15, 2021

Last Update Submit

September 25, 2023

Conditions

Keywords

intraneural blood flow

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

EXPERIMENTAL

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.

Behavioral: CoolingBehavioral: HeatingBehavioral: ExercisingBehavioral: TypingBehavioral: Using a mouseBehavioral: Cooking

Interventions

CoolingBEHAVIORAL

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

Experimental Group
HeatingBEHAVIORAL

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

Experimental Group
ExercisingBEHAVIORAL

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.

Experimental Group
TypingBEHAVIORAL

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.

Experimental Group
Using a mouseBEHAVIORAL

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.

Experimental Group
CookingBEHAVIORAL

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.

Experimental Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Ohio State University; School of Health and Rehabilitation Sciences

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Cool-Down ExerciseHeatingCooking

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Post-Exercise Recovery TechniquesPhysical Therapy ModalitiesTherapeuticsRehabilitationExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEnvironment, ControlledEnvironmentEnvironment and Public HealthFood HandlingFood IndustryIndustryTechnology, Industry, and Agriculture

Study Officials

  • Shawn C Roll, PhD

    University of Southern California

    STUDY DIRECTOR

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

Locations