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Enhanced External Counterpulsation on Delayed Onset Muscle Soreness

Sponsor
David Grant U.S. Air Force Medical Center (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT02175316
Collaborator
(none)
18
Enrollment
1
Location
1
Arm
41.2
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Enhanced External Counterpulsation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effects of Enhanced External Counterpulsation on Delayed Onset Muscle Soreness, a Pilot Study
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Jul 25, 2017
Actual Study Completion Date :
Sep 6, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in delayed onset muscle soreness over time. [At 3, 6, 9, 12, 15, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 Hours]

      Likert pain surveys

    Secondary Outcome Measures

    1. Pain tolerance [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.

    2. Bio-markers for muscle inflammation [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 59 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 David Grant USAF Medical Center Travis Air Force Base California United States 94535

    Sponsors and Collaborators

    • David Grant U.S. Air Force Medical Center

    Investigators

    • Principal Investigator: Sachin Shah, United States Air Force

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Grant U.S. Air Force Medical Center
    ClinicalTrials.gov Identifier:
    NCT02175316
    Other Study ID Numbers:
    • FDG20130045H
    First Posted:
    Jun 26, 2014
    Last Update Posted:
    Apr 22, 2020
    Last Verified:
    Sep 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Myalgia

    Study Results

    No Results Posted as of Apr 22, 2020