The Effect of Transcutaneous Electrical Nerve Stimulation on People With Muscle Fatigue Due to Training, Sports

Muscle Fatigue Clinical Trial

Official title:

The Effect of Transcutaneous Electrical Nerve Stimulation on People With Muscle Fatigue Due to Training, Sports

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04082156
• Other study ID #: HI794-0014
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: March 2020
• Source: Omron Healthcare Co., Ltd.
• Contact: Daryl Lawson, DSc
• Phone: 336-278-6352
• Email: daryl.lawson[@]wmich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective is to assess if TENS will improve the muscle recovery rate from post-exercise fatigue.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• No phobia of electrical stimulation

• No pain or anti-inflammatory medication will be taken during study

• English speaking

Exclusion Criteria:

• Pregnancy

• Diabetes Mellitus

• Neuropathy

• Smoker

• Uncontrolled Hypertension

• Past surgery in the region to be treated by TENS or had received an intra-articular corticosteroid or hyaluronic acid injection within 6 months prior to enrollment

• Rhumatoid Arthritis (RA) in the area to be treated by TENS

• Allergic to tape/electrodes

• Dementia

• History of knee joint replacement or tibial osteotomy

• Undergoing physical therapy

• Any major joint pain (e.g., back, hip, or ankle) that could limit functional ability

• Contraindications to TENS such as having a pacemakers, dermatological conditions, and abnormal sensation of the lower extremity.

Related Conditions & MeSH terms

• Fatigue
• Muscle Fatigue

Intervention

Device:
• electrical stimulation
electrical stimulation
• Sham
no stimulation

Locations

Country	Name	City	State
Japan	Omron healthcare Co.,Ltd.	Muko

Sponsors (2)

Lead Sponsor	Collaborator
Omron Healthcare Co., Ltd.	Western Michigan University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS(Visual Analog Scale score) for soreness or pain	Participants will record their level of knee pain by drawing a vertical mark between the ends of a 10-cm horizontal line. The 0-cm end and the 10-cm end represented no pain and the most extreme pain, respectively. The distance from the 0-cm end to the drawn mark was recorded to the first decimal place.	2weeks
Primary	FI (Fatugue Index)	A system called "Just Jump" by Probotics* will be used to induce DOMS. The goal of the jump is to create fatigue of the lower extremities which is a byproduct of decreased power. It will also create exercise induces DOMS. Using this system the next day will test the fatigue and power of the lower extremities to see if it has changed.	2weeks
Secondary	sleep quality measurement	Each subject will be provided with Sleep measurment device. The device captures sleep data via a sensor to monitor breathing, body movemement along with ambient light and temperature in the bedroom. The device is composed of six sleep parameters that combine to reflect the overall quality of sleep. It has objective sleep data, SleepScore (Objective Sleep Quality), MindScore (Objective REM Sleep Quality), BodyScore (Objective Deep Sleep Quality), Total Record Time, Time in Bed, Total Sleep Time, REM Sleep Time, Light Sleep Time, Deep Sleep time, Onset Time, WASO, Total Wake Time, Interruptions.	2weeks
Secondary	POMS (Profile of Mood States)	It will be used for mental alertness. It is short form containing 24 items and four scales. Used in sports science (along with other areas) to evaluate and access mood after exercise or a sporting event concerned the certain scales containing "vigour" and "fatigue".	2weeks