Back to resultsEnhanced External Counterpulsation on Delayed Onset Muscle Soreness
Primary Purpose
Muscle Tightness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced External Counterpulsation
Sponsored by
About this trial
This is an interventional prevention trial for Muscle Tightness
Eligibility Criteria
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
Sites / Locations
- David Grant USAF Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: EECP for DOMS
Arm Description
All enrolled subjects will receive EECP treatment Delayed Onset Muscle Soreness.
Outcomes
Primary Outcome Measures
Change in delayed onset muscle soreness over time.
Likert pain surveys
Secondary Outcome Measures
Pain tolerance
Pain tolerance measured by mmHg pressure required to elicit a delayed-onset muscle pain response.
Bio-markers for muscle inflammation
Bio-markers for muscle inflammation: C-reactive protein, creatine phosphokinase, and white blood cell count.
Full Information
NCT ID
NCT02175316
First Posted
May 21, 2014
Last Updated
April 20, 2020
Sponsor
David Grant U.S. Air Force Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02175316
Brief Title
Enhanced External Counterpulsation on Delayed Onset Muscle Soreness
Official Title
Effects of Enhanced External Counterpulsation on Delayed Onset Muscle Soreness, a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 25, 2017 (Actual)
Study Completion Date
September 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
David Grant U.S. Air Force Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Tightness
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: EECP for DOMS
Arm Type
Experimental
Arm Description
All enrolled subjects will receive EECP treatment Delayed Onset Muscle Soreness.
Intervention Type
Device
Intervention Name(s)
Enhanced External Counterpulsation
Other Intervention Name(s)
Lumenair Enhanced External Counterpulsation Therapy System, Vasomedical
Intervention Description
Enhanced External Counterpulsation
Primary Outcome Measure Information:
Title
Change in delayed onset muscle soreness over time.
Description
Likert pain surveys
Time Frame
At 3, 6, 9, 12, 15, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 Hours
Secondary Outcome Measure Information:
Title
Pain tolerance
Description
Pain tolerance measured by mmHg pressure required to elicit a delayed-onset muscle pain response.
Time Frame
Baseline, 24 hours, 2 days 3 days 4 days 33 days
Title
Bio-markers for muscle inflammation
Description
Bio-markers for muscle inflammation: C-reactive protein, creatine phosphokinase, and white blood cell count.
Time Frame
Baseline, 24 hours, 2 days 3 days 4 days 33 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sachin Shah
Organizational Affiliation
United States Air Force
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Grant USAF Medical Center
City
Travis Air Force Base
State/Province
California
ZIP/Postal Code
94535
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Enhanced External Counterpulsation on Delayed Onset Muscle Soreness
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