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

Primary Purpose

Focus of Study is to Determine Efficacy of Compex

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compex unit's Active Recovery® program
Ice application
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focus of Study is to Determine Efficacy of Compex focused on measuring Compex, ice

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Michigan State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

No Intervention

Arm Label

'Compex unit's Active Recovery® program'

Ice application

Control

Arm Description

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.

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).

This is a control group where subjects will not perform an intervention.

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

Full Information

First Posted
October 16, 2013
Last Updated
August 28, 2014
Sponsor
Michigan State University
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1. Study Identification

Unique Protocol Identification Number
NCT01967121
Brief Title
Compex Use With Delayed Onset Muscle Soreness: A Comparison to Other Methods
Official Title
Compex Use With Delayed Onset Muscle Soreness: A Comparison to Other Methods
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focus of Study is to Determine Efficacy of Compex
Keywords
Compex, ice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
'Compex unit's Active Recovery® program'
Arm Type
Experimental
Arm Description
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.
Arm Title
Ice application
Arm Type
Other
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
This is a control group where subjects will not perform an intervention.
Intervention Type
Device
Intervention Name(s)
Compex unit's Active Recovery® program
Intervention Description
Compex unit's Active Recovery® program will be performed for 15 minutes once per day.
Intervention Type
Other
Intervention Name(s)
Ice application
Intervention Description
Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present
Primary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Description
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'.
Time Frame
Day 1 through Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracey Covassin, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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