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

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

Study Overview

• Status: Unknown
• Conditions: Muscle Fatigue
• Intervention / Treatment: Device: electrical stimulation; Device: Sham

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daryl Lawson, DSc; Phone Number: 336-278-6352; Email: daryl.lawson@wmich.edu

Study Locations

• Japan
  • Muko, Japan
    • Recruiting
    • Omron healthcare Co.,Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham TENS	Device: Sham; no stimulation
Active Comparator: Active TENS	Device: electrical stimulation; electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Omron Healthcare Co., Ltd.
• Collaborators: Western Michigan University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): May 30, 2020

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: TENS, DOMS, soreness, fatigue
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: HI794-0014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes