Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05057754
Other study ID # HS-21-04511
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 13, 2021
Est. completion date May 30, 2022

Study information

Verified date September 2023
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Ohio State University; School of Health and Rehabilitation Sciences Columbus Ohio
United States USC; Musculoskeletal Sonography & Occupational Performance Laboratory Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT05067205 - Minimal Invasive Carpal Tunnel Release With the Novel Device N/A
Completed NCT03184688 - Platelet Rich Plasma for Carpal Tunnel Syndrome N/A
Completed NCT03582735 - Preoperative Neuromobilization Exercises for Individuals With Carpal Tunnel Syndrome N/A
Completed NCT05490420 - Effects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome N/A
Recruiting NCT05970692 - Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale
Completed NCT04043780 - Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome N/A
Completed NCT03880812 - Cost Information on Carpal Tunnel Syndrome Treatment Decisions N/A
Recruiting NCT05503719 - An Absorbable Suture Versus a Non-absorbable Suture in Carpal Tunnel Release, a Randomized Controlled Trial N/A
Recruiting NCT05372393 - Carpal Tunnel Release Under Local Infiltration Anaesthesia Versus Local Infiltration Anaesthesia and Median Nerve Block N/A
Recruiting NCT05328180 - aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE) N/A
Recruiting NCT05466162 - Soft Tissue Massage Along With Mobilization Technique on Symptoms and Functional Status of Carpal Tunnel Syndrome N/A
Completed NCT04060875 - Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
Not yet recruiting NCT06294821 - 4AP to Delay Carpal Tunnel Release (CTR) Phase 2/Phase 3
Not yet recruiting NCT04328805 - Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome. Phase 4
Terminated NCT02791529 - Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release Phase 1
Completed NCT02141035 - Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome Phase 2/Phase 3
Completed NCT01887145 - Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome N/A
Recruiting NCT01897272 - Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective Study N/A
Completed NCT01394822 - Neuromuscular Ultrasound for Focal Neuropathies N/A
Enrolling by invitation NCT01017471 - Carpal Tunnel Syndrome Release Using PSU Retractor Phase 3