Focus of Study is to Determine Efficacy of CompexNCT01967121
Compex Use With Delayed Onset Muscle Soreness: A Comparison to Other Methods
A study testing Compex unit's Active Recovery® program and Ice application in people with Focus of Study is to Determine Efficacy of Compex, run by Michigan State University at 1 site in United States.
Trial summary
The purpose of this research study is to determine if the application of ice, control group, or a muscle stimulation program from the Compex® series can help reduce or eliminate delayed muscle soreness from performing leg extension and flexion. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus of Study is to Determine Efficacy of Compex
- What is being tested?
- Compex unit's Active Recovery® program and Ice application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The studied population will be composed of 45 physically active college students between the ages of 18-30 years old.
- Inclusionary criteria will be participation in a physical activity as defined by the ACSM, which can be a mixture of moderate (i.e., sufficient to raise the heart rate and begin to sweat) and vigorous (i.e., breathing hard and fast with a rapidly rising heart rate) intensity aerobic activity and muscle strengthening (i.e., weights lifted to the point where anther repetition cannot be completed without help) activities two or more time per week (ACSM, 2011.)
Who cannot join
- Exclusionary criteria will be surgery within the last six months requiring immobilization for more than four weeks, discomfort performing intense physical activity, diseases like muscular dystrophy that predispose muscular damage beyond reasonable levels resulting from physical activity, and current injury of the knees or hips.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University
East Lansing, Michigan, 48824
About this study
The purpose of this research study is to determine if the application of ice, control group, or a muscle stimulation program from the Compex® series can help reduce or eliminate delayed muscle soreness from performing leg extension and flexion. Individuals will complete a health history questionnaire to determine if they qualify for this study. We will measure your leg girth with a measuring tape and take a pain measurement of your hamstrings by using a spring to press down on your leg. Individuals will then warm-up on a bike without resistance for 5 minutes followed by 10 regular leg extension and flexion exercises. Individuals will then perform 6 sets of 10 leg extension and flexion exercises on a biodex machine (similar to leg curl machines in the gym). Individuals will perform each set to the maximum effort of their capables. After each set of 10 individuals will have a 2 minute rest. We will ask you to rank your leg soreness on a scale from 1-10.
Individuals will then be assigned to a modality of either ice, control group or compex. Individuals will perform the modality (ice, control, compex) we assign you to until you are no longer sore.
Read more
Over the next five days individuals will return to measure their level of soreness, leg girth and pain pressure.
This study will examine the following hypotheses:
H1: There will be no difference in pressure pain threshold after using the Compex compared to other groups.
H2: There will be no difference in perceived soreness after using the Compex compared to other groups.
H3: There will be no difference in muscular strength after using the Compex compared to other groups.
H4: There will be no difference in active range of motion after using the Compex compared to other groups.
- Being tested
- Compex unit's Active Recovery® program, Ice application
- Keywords
- Compex, ice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compex unit's Active Recovery® programDevice
Compex unit's Active Recovery® program will be performed for 15 minutes once per day.
Ice applicationOther
Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present
| Study group | Role | What they receive |
|---|---|---|
| 'Compex unit's Active Recovery® program' | Experimental | The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity. Receives: Device: Compex unit's Active Recovery® program |
| Ice application | Other | A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS). Receives: Other: Ice application |
| Control | No intervention | This is a control group where subjects will not perform an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Visual Analog Scale
Visual Analog Scale for Muscle Soreness scale The scale for measuring the intensity of muscle soreness will be a 10 cm visual analog scale, spaced by one centimeter increments from one to 10. Ten will represent the maximum amount of soreness and zero represents no soreness at all. Subjects will be asked to complete this scale once per day at the same time of day until the soreness has dissipated. The Visual Analog Scale for muscle soreness is measured as 'scores on a scale'.
Measured: Day 1 through Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Focus of Study is to Determine Efficacy of CompexStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracey Covassin, Michigan State University
- Investigators
- Tracey Covassin, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967121
- Sponsor's protocol ID
- IRB# 13-849F
- Status last verified
- Aug 2014
- First submitted
- 16 Oct 2013
- Last updated
- 29 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compex Use With Delayed Onset Muscle Soreness: A Comparison to Other Methods
- ClinicalTrials.gov ID
- NCT01967121
- Acronym / sponsor ID
- IRB# 13-849F
- Keywords
- Compex, ice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Posted 29 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine if the application of ice, control group, or a muscle stimulation program from the Compex® series can help reduce or eliminate delayed muscle soreness from performing leg extension and flexion. Individuals will complete a health history questionnaire to determine if they qualify for this study. We will measure your leg girth with a measuring tape and take a pain measurement of your hamstrings by using a spring to press down on your leg. Individuals will then warm-up on a bike without resistance for 5 minutes followed by 10 regular leg extension and flexion exercises. Individuals will then perform 6 sets of 10 leg extension and flexion exercises on a biodex machine (similar to leg curl machines in the gym). Individuals will perform each set to the maximum effort of their capables. After each set of 10 individuals will have a 2 minute rest. We will ask you to rank your leg soreness on a scale from 1-10.
Individuals will then be assigned to a modality of either ice, control group or compex. Individuals will perform the modality (ice, control, compex) we assign you to until you are no longer sore.
Over the next five days individuals will return to measure their level of soreness, leg girth and pain pressure.
This study will examine the following hypotheses:
H1: There will be no difference in pressure pain threshold after using the Compex compared to other groups.
H2: There will be no difference in perceived soreness after using the Compex compared to other groups.
H3: There will be no difference in muscular strength after using the Compex compared to other groups.
H4: There will be no difference in active range of motion after using the Compex compared to other groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 'Compex unit's Active Recovery® program' | Experimental | Device: Compex unit's Active Recovery® programThe Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity. |
| Ice application | Other | Other: Ice applicationA randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS). |
| Control | No intervention | –This is a control group where subjects will not perform an intervention. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The studied population will be composed of 45 physically active college students between the ages of 18-30 years old.
- Inclusionary criteria will be participation in a physical activity as defined by the ACSM, which can be a mixture of moderate (i.e., sufficient to raise the heart rate and begin to sweat) and vigorous (i.e., breathing hard and fast with a rapidly rising heart rate) intensity aerobic activity and muscle strengthening (i.e., weights lifted to the point where anther repetition cannot be completed without help) activities two or more time per week (ACSM, 2011.)
Key exclusion criteria (1 listed)
- Exclusionary criteria will be surgery within the last six months requiring immobilization for more than four weeks, discomfort performing intense physical activity, diseases like muscular dystrophy that predispose muscular damage beyond reasonable levels resulting from physical activity, and current injury of the knees or hips.
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 |
|---|---|---|
| Compex unit's Active Recovery® programCompex unit's Active Recovery® program will be performed for 15 minutes once per day. | Device | 'Compex unit's Active Recovery® program' |
| Ice applicationParticipants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present | Other | Ice application |
Primary outcome
Pain Scores on the Visual Analog Scale
Time frame: Day 1 through Day 5
Visual Analog Scale for Muscle Soreness scale The scale for measuring the intensity of muscle soreness will be a 10 cm visual analog scale, spaced by one centimeter increments from one to 10. Ten will represent the maximum amount of soreness and zero represents no soreness at all. Subjects will be asked to complete this scale once per day at the same time of day until the soreness has dissipated. The Visual Analog Scale for muscle soreness is measured as 'scores on a scale'.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Tracey Covassin, PhD principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compex unit's Active Recovery® program and Ice application in people with Focus of Study is to Determine Efficacy of Compex, run by Michigan State University 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 2 inclusion and 1 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 29 Aug 2014. 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?
Yes. Results are posted in the registry (first posted 29 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Scores on the Visual Analog Scale (time frame: Day 1 through Day 5). 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 29 Aug 2014.