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Compex Use With Delayed Onset Muscle Soreness: A Comparison to Other Methods

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ClinicalTrials.gov Identifier: NCT01967121
Recruitment Status : Completed
First Posted : October 22, 2013
Results First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Tracey Covassin, Michigan State University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Focus of Study is to Determine Efficacy of Compex Device: Compex unit's Active Recovery® program Other: Ice application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compex Use With Delayed Onset Muscle Soreness: A Comparison to Other Methods
Study Start Date : October 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: 'Compex unit's Active Recovery® program'
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.
Device: Compex unit's Active Recovery® program
Compex unit's Active Recovery® program will be performed for 15 minutes once per day.

Ice application
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).
Other: Ice application
Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present

No Intervention: Control
This is a control group where subjects will not perform an intervention.



Primary Outcome Measures :
  1. 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'.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967121


Locations
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United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
Sponsors and Collaborators
Michigan State University
Investigators
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Principal Investigator: Tracey Covassin, PhD Michigan State University

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Responsible Party: Tracey Covassin, Associate Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT01967121     History of Changes
Other Study ID Numbers: IRB# 13-849F
First Posted: October 22, 2013    Key Record Dates
Results First Posted: August 29, 2014
Last Update Posted: August 29, 2014
Last Verified: August 2014

Keywords provided by Tracey Covassin, Michigan State University:
Compex, ice

Additional relevant MeSH terms:
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Myalgia
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Signs and Symptoms