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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01967121
Other study ID # IRB# 13-849F
Secondary ID
Status Completed
Phase N/A
First received October 16, 2013
Last updated August 28, 2014
Start date October 2013
Est. completion date April 2014

Study information

Verified date August 2014
Source Michigan State University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 30 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Focus of Study is to Determine Efficacy of Compex
  • Myalgia

Intervention

Device:
Compex unit's Active Recovery® program
Compex unit's Active Recovery® program will be performed for 15 minutes once per day.
Other:
Ice application
Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present

Locations

Country Name City State
United States Michigan State University East Lansing Michigan

Sponsors (1)

Lead Sponsor Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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'. Day 1 through Day 5 No