NCT02175316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2017

Completed
Last Updated

April 22, 2020

Status Verified

September 1, 2017

Enrollment Period

3.3 years

First QC Date

May 21, 2014

Last Update Submit

April 20, 2020

Conditions

Muscle Tightness

Outcome Measures

Primary Outcomes (1)

  • Change in delayed onset muscle soreness over time.

    Likert pain surveys

    At 3, 6, 9, 12, 15, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 Hours

Secondary Outcomes (2)

  • Pain tolerance

    Baseline, 24 hours, 2 days 3 days 4 days 33 days

  • Bio-markers for muscle inflammation

    Baseline, 24 hours, 2 days 3 days 4 days 33 days

Study Arms (1)

Experimental: EECP for DOMS

EXPERIMENTAL

All enrolled subjects will receive EECP treatment Delayed Onset Muscle Soreness.

Device: Enhanced External Counterpulsation

Interventions

Enhanced External CounterpulsationDEVICE

Enhanced External Counterpulsation

Also known as: Lumenair Enhanced External Counterpulsation Therapy System, Vasomedical
Experimental: EECP for DOMS

Eligibility Criteria

Age25 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Grant USAF Medical Center

Travis Air Force Base, California, 94535, United States

Location

Study Officials

  • Sachin Shah

    United States Air Force

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2014

First Posted

June 26, 2014

Study Start

April 1, 2014

Primary Completion

July 25, 2017

Study Completion

September 6, 2017

Last Updated

April 22, 2020

Record last verified: 2017-09

Locations

US(1)