Myalgia [C05.651.542]Phase 4CLMDNCT02327988
Cryotherapy and Laser Therapy on Muscle Damage
A Phase 4 study testing Cryotherapy and Laser therapy in people with Myalgia [C05.651.542], run by Universidade Federal do Rio Grande do Norte.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Myalgia [C05.651.542]
- What is being tested?
- Cryotherapy and Laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- Not understanding the commands given in the protocols and/or inadequate performance during assessments.
About this study
Official title: 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.
- Conditions
- Myalgia [C05.651.542]
- Being tested
- Cryotherapy, Laser therapy
- Keywords
- cryotherapy, laser therapy, eccentric exercise, delayed onset muscle soreness, muscle damage, dynamometry, electromyography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
Laser therapyDevice
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | 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 Receives: Other: Cryotherapy |
| Laser therapy | Experimental | The laser therapy group received laser application to the muscle belly of the non-dominant upper limb brachial biceps at four different points. Receives: Device: Laser therapy |
| Control | No intervention | The control group did not undergo any intervention and remained at rest for 25 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain sensation
Through the VAS (visual analogue scale).
Measured: Within the first 3 days
Secondary outcomes (2)
Strength
The strength will be measure through isokinetic dynamometry and the variables analyzed will be peak torque normalized for body weight and power.
Measured: Within the first 3 days
Muscle activation
Measured by surface electromyography.
Measured: Within the first 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myalgia [C05.651.542]Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327988
- Sponsor's protocol ID
- 387.826
- Acronym
- CLMD
- Status last verified
- Dec 2014
- First submitted
- 11 Dec 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotherapy and Laser Therapy do Not Interfere in the Response to Eccentric Exercise-induced Muscle Damage: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02327988
- Acronym / sponsor ID
- CLMD / 387.826
- Conditions
- Myalgia [C05.651.542]
- Keywords
- cryotherapy, laser therapy, eccentric exercise, delayed onset muscle soreness, muscle damage, dynamometry, electromyography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Other: CryotherapyTo 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 |
| Laser therapy | Experimental | Device: Laser therapyThe laser therapy group received laser application to the muscle belly of the non-dominant upper limb brachial biceps at four different points. |
| Control | No intervention | –The control group did not undergo any intervention and remained at rest for 25 minutes. |
Who may qualify
- Ages
- 18 to 28 years
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Not understanding the commands given in the protocols and/or inadequate performance during assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryotherapy | Other | Cryotherapy |
| Laser therapy | Device | Laser therapy |
Primary outcome
Pain sensation
Time frame: Within the first 3 days
Through the VAS (visual analogue scale).
2 secondary outcomes
Strength
Time frame: Within the first 3 days
Muscle activation
Time frame: Within the first 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cryotherapy and Laser therapy in people with Myalgia [C05.651.542], run by Universidade Federal do Rio Grande do Norte.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain sensation (time frame: Within the first 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.