Trial Outcomes & Findings for Compex Use With Delayed Onset Muscle Soreness: A Comparison to Other Methods (NCT NCT01967121)

Results Overview

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'.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

Day 1 through Day 5

Results posted on

2014-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	'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. 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). Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present	Control This is a control group where subjects will not perform an intervention.
Overall Study STARTED	25	25	25
Overall Study COMPLETED	25	25	25
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	'Compex Unit's Active Recovery® Program' n=25 Participants 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. Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day.	Ice Application n=25 Participants 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). Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present	Control n=25 Participants This is a control group where subjects will not perform an intervention.	Total n=75 Participants Total of all reporting groups
Age, Continuous	19.43 years STANDARD_DEVIATION 1.25 • n=5 Participants	19.61 years STANDARD_DEVIATION 1.68 • n=7 Participants	19.78 years STANDARD_DEVIATION 1.89 • n=5 Participants	19.64 years STANDARD_DEVIATION 1.61 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	45 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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'.

Outcome measures

Outcome measures
Measure	'Compex Unit's Active Recovery® Program' n=25 Participants 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. Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day.	Ice Application n=25 Participants 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). Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present	Control n=25 Participants This is a control group where subjects will not perform an intervention.
Pain Scores on the Visual Analog Scale Day 1	2.64 scores on a scale Standard Deviation 2.21	2.60 scores on a scale Standard Deviation 2.81	2.45 scores on a scale Standard Deviation 2.10
Pain Scores on the Visual Analog Scale Day 2	.80 scores on a scale Standard Deviation 1.5	.72 scores on a scale Standard Deviation 1.24	.85 scores on a scale Standard Deviation 1.5
Pain Scores on the Visual Analog Scale Day 3	.4 scores on a scale Standard Deviation .82	.56 scores on a scale Standard Deviation 1.23	.88 scores on a scale Standard Deviation 1.72
Pain Scores on the Visual Analog Scale Day 4	.16 scores on a scale Standard Deviation .55	.44 scores on a scale Standard Deviation .92	.70 scores on a scale Standard Deviation 1.78
Pain Scores on the Visual Analog Scale DAY 5	.04 scores on a scale Standard Deviation .2	.16 scores on a scale Standard Deviation .55	.4 scores on a scale Standard Deviation 1.39

Adverse Events

'Compex Unit's Active Recovery® Program'

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ice Application

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tracey Covassin

Michigan State University

Phone: 517-353-2010

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place