- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02327988
Cryotherapy and Laser Therapy on Muscle Damage (CLMD)
December 25, 2014 updated by: Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte
Cryotherapy and Laser Therapy do Not Interfere in the Response to Eccentric Exercise-induced Muscle Damage: a Randomized Clinical Trial.
This study propose investigate the effect of cryotherapy and laser therapy in response to strenuous exercise-induced muscle damage on the biceps brachii muscle (muscle of the arms).
All the individuals underwent to an strenuous exercise protocol (2 series of 10 contractions of non-dominant elbow flexors) and three assessments (pre, post and 48hr after the exercise), composed of pain sensation, measure of the strength and muscle activation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 28 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Female sex
- Aged between 18 and 28 years
- Healthy, considered active according to the International Physical Activity Questionnaire -Short Form (IPAQ)
- Engaging in physical activity involving upper limbs at least 2 times a week
- Exhibiting shoulder joint, elbow and non-dominant hand integrity
- Not having a history of osteo-myoarticular injuries in the assessed limb in the last 6 months, or neurological, visual and/or non-corrected auditory impairments.
- Furthermore they could not be allergic to ice (verified by the ice cube test) or any absolute contraindication for the use of laser (cancer and pregnancy).
Exclusion Criteria:
- Not understanding the commands given in the protocols and/or inadequate performance during assessments.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cryotherapy
To the cryotherapy group a 1kg ice pack was strapped over the entire brachial biceps muscle and adjacent muscles of the arm under study using a bandage, and the application lasted 25 minute laser
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Experimental: Laser therapy
The laser therapy group received laser application to the muscle belly of the non-dominant upper limb brachial biceps at four different points.
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No Intervention: Control
The control group did not undergo any intervention and remained at rest for 25 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain sensation
Time Frame: Within the first 3 days
|
Through the VAS (visual analogue scale).
|
Within the first 3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength
Time Frame: Within the first 3 days
|
The strength will be measure through isokinetic dynamometry and the variables analyzed will be peak torque normalized for body weight and power.
|
Within the first 3 days
|
|
Muscle activation
Time Frame: Within the first 3 days
|
Measured by surface electromyography.
|
Within the first 3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
December 11, 2014
First Submitted That Met QC Criteria
December 25, 2014
First Posted (Estimate)
December 31, 2014
Study Record Updates
Last Update Posted (Estimate)
December 31, 2014
Last Update Submitted That Met QC Criteria
December 25, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 387.826
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.