The Effect of Transcutaneous Electrical Nerve Stimulation on People With Muscle Fatigue Due to Training, Sports
1 other identifier
interventional
30
1 country
1
Brief Summary
The objective is to assess if TENS will improve the muscle recovery rate from post-exercise fatigue.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
1 active site
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
Study Start
First participant enrolled
July 15, 2019
CompletedFirst Submitted
Initial submission to the registry
August 28, 2019
CompletedFirst Posted
Study publicly available on registry
September 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2020
CompletedMarch 13, 2020
March 1, 2020
10 months
August 28, 2019
March 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
sleep quality measurement
2weeks
POMS (Profile of Mood States)
2weeks
Study Arms (2)
Active TENS
ACTIVE COMPARATORSham TENS
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- No phobia of electrical stimulation
- No pain or anti-inflammatory medication will be taken during study
- English speaking
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Omron Healthcare Co., Ltd.lead
- Western Michigan Universitycollaborator
Study Sites (1)
Omron healthcare Co.,Ltd.
Mukō, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2019
First Posted
September 9, 2019
Study Start
July 15, 2019
Primary Completion
April 30, 2020
Study Completion
May 30, 2020
Last Updated
March 13, 2020
Record last verified: 2020-03