Enhanced External Counterpulsation on Delayed Onset Muscle Soreness

April 20, 2020 updated by: David Grant U.S. Air Force Medical Center

Effects of Enhanced External Counterpulsation on Delayed Onset Muscle Soreness, a Pilot Study

This study will evaluate the effects of Enhanced External Counterpulsation on delayed onset muscle soreness. The primary outcomes will be duration of delayed onset muscle soreness, WBC count, CRP count, CPK count, and pain tolerance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Travis Air Force Base, California, United States, 94535
        • David Grant USAF Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 57 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy active Duty or DoD beneficiaries between 25 and 59 years old

Exclusion Criteria:

  • Not on a physical profile
  • Not taking any OTC or prescription pain medications or workout supplements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: EECP for DOMS
All enrolled subjects will receive EECP treatment Delayed Onset Muscle Soreness.
Device: Enhanced External Counterpulsation
Enhanced External Counterpulsation
Other Names:
  • Lumenair Enhanced External Counterpulsation Therapy System, Vasomedical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in delayed onset muscle soreness over time.
Time Frame: At 3, 6, 9, 12, 15, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 Hours
Likert pain surveys
At 3, 6, 9, 12, 15, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain tolerance
Time Frame: Baseline, 24 hours, 2 days 3 days 4 days 33 days
Pain tolerance measured by mmHg pressure required to elicit a delayed-onset muscle pain response.
Baseline, 24 hours, 2 days 3 days 4 days 33 days
Bio-markers for muscle inflammation
Time Frame: Baseline, 24 hours, 2 days 3 days 4 days 33 days
Bio-markers for muscle inflammation: C-reactive protein, creatine phosphokinase, and white blood cell count.
Baseline, 24 hours, 2 days 3 days 4 days 33 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Grant U.S. Air Force Medical Center

Investigators

  • Principal Investigator: Sachin Shah, United States Air Force

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

July 25, 2017

Study Completion (Actual)

September 6, 2017

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Actual)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDG20130045H

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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