Muscle TightnessNCT02175316
Enhanced External Counterpulsation on Delayed Onset Muscle Soreness
A study testing Enhanced External Counterpulsation in people with Muscle Tightness, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Tightness
- What is being tested?
- Enhanced External Counterpulsation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 6 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy active Duty or DoD beneficiaries between 25 and 59 years old
Who cannot join
- Not on a physical profile
- Not taking any OTC or prescription pain medications or workout supplements
Trial locations and contacts
1 site in 1 country.
United States1 site
David Grant USAF Medical Center
Travis Air Force Base, California, 94535
About this study
Official title: 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.
- Conditions
- Muscle Tightness
- Being tested
- Enhanced External Counterpulsation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced External CounterpulsationDevice
Also called Lumenair Enhanced External Counterpulsation Therapy System, Vasomedical
Enhanced External Counterpulsation
| Study group | Role | What they receive |
|---|---|---|
| Experimental: EECP for DOMS | Experimental | All enrolled subjects will receive EECP treatment Delayed Onset Muscle Soreness. Receives: Device: Enhanced External Counterpulsation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in delayed onset muscle soreness over time.
Likert pain surveys
Measured: At 3, 6, 9, 12, 15, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 Hours
Secondary outcomes (2)
Pain tolerance
Pain tolerance measured by mmHg pressure required to elicit a delayed-onset muscle pain response.
Measured: Baseline, 24 hours, 2 days 3 days 4 days 33 days
Bio-markers for muscle inflammation
Bio-markers for muscle inflammation: C-reactive protein, creatine phosphokinase, and white blood cell count.
Measured: Baseline, 24 hours, 2 days 3 days 4 days 33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startApr 2014
- Primary completion25 Jul 2017
- Study completion6 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle TightnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Grant U.S. Air Force Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sachin Shah, Principal investigator, United States Air Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175316
- Sponsor's protocol ID
- FDG20130045H
- Status last verified
- Sep 2017
- First submitted
- 21 May 2014
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Enhanced External Counterpulsation on Delayed Onset Muscle Soreness, a Pilot Study
- ClinicalTrials.gov ID
- NCT02175316
- Acronym / sponsor ID
- FDG20130045H
- Conditions
- Muscle Tightness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- David Grant U.S. Air Force Medical CenterUS federal agency
- Study start
- Apr 2014
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 6 Sep 2017 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: EECP for DOMS | Experimental | Device: Enhanced External CounterpulsationAll enrolled subjects will receive EECP treatment Delayed Onset Muscle Soreness. |
Who may qualify
- Ages
- 25 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy active Duty or DoD beneficiaries between 25 and 59 years old
Key exclusion criteria (2 listed)
- Not on a physical profile
- Not taking any OTC or prescription pain medications or workout supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced External CounterpulsationAlso: Lumenair Enhanced External Counterpulsation Therapy System, VasomedicalEnhanced External Counterpulsation | Device | Experimental: EECP for DOMS |
Primary outcome
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
2 secondary outcomes
Pain tolerance
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sachin Shah principal investigator
United States Air Force
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced External Counterpulsation in people with Muscle Tightness, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.