AthletesNCT04628403
Effects of Clinical Interventions for the Management of Late Start
A study testing massage, lasertherapy and shock waves in people with Athletes, run by São Paulo State University at 1 site in Brazil.
Trial summary
Introduction: Late-onset muscle pain (DOMS) is characterized by a type of temporary muscle damage, common after high-intensity exercise. In addition to pain, DOMS clinically generates muscle stiffness, reduced joint range of motion, muscle weakness and reduced peak torque. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletes
- What is being tested?
- massage, lasertherapy and shock waves
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Nov 2020to 20 Mar 2021
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Professional athletes;
- Age over 18 years;
- Both sexes;
- Not having recent injuries
Who cannot join
- Participants who do not complete all the proposed collection moments
- who do not agree to participate will be excluded.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Estado do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 78060-900
Roberto L Nahon, Dr, 66999202206, robertonahon@gmail.com
Jaqueline S Lopes, +5566999202206, jaqueee-santosss@hotmail.com
About this study
Official title: Effects of Clinical Interventions for the Management of Late Start Muscular Pain (Doms) in the Post-exercise Recovery Process
Introduction: Late-onset muscle pain (DOMS) is characterized by a type of temporary muscle damage, common after high-intensity exercise. In addition to pain, DOMS clinically generates muscle stiffness, reduced joint range of motion, muscle weakness and reduced peak torque. In this regard, in order to accelerate the recovery of body systems and treat symptoms of DOMS, the management of different types of interventions has been observed, supporting the clinical practice, based on evidence. Objectives: To investigate the effect of different types of clinical interventions for the treatment of DOMS. Material and methods: For the clinical trial, 50 ultramarathon and rowing athletes of both sexes, aged between 18 and 60 years old, will be recruited randomly into four possible groups: control (CG), shock waves (G1) , massage (G2) and laser therapy (G3). The evaluation moments will be as follows: minutes before exercise (M1); immediately after exercise (M2); immediately after applying the recovery technique (M3); and 24 hours after exercise (M4) and the evaluated outcomes will be: pain, psychological aspects, functional test and blood markers.
- Conditions
- Athletes
- Being tested
- massage, lasertherapy, shock waves
- Keywords
- Lasertherapy, Shockwaves, Massage, Sports Medicine, Athletic Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageOther
clinical interventions, of mechanophysiological origin for the treatment of symptoms corresponding to DOMS, after exercise
lasertherapyDevice
lasertherapy
shock wavesDevice
shock waves
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| shock waves | Experimental | Not described Receives: Device: shock waves |
| massage | Experimental | Not described Receives: Other: massage |
| lasertherapy | Experimental | Not described Receives: Device: lasertherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAIN
pain systemic and located in quadriceps, assessed using a visual analog scale (0-10), with 0 indicating no pain and 10 the worst possible pain
Measured: 7 days
SATISFACTION
Brunel's Mood Scale (BRUMS), with ratings from 0 to 4 where, 0 represents nothing; 1 represents a little, 2 indicates moderately; 3 reports a lot; and 4 corresponds to extremely
Measured: 7 days
Secondary outcomes (1)
MUSCLE STRENGTH
measured through a functional test entitled sit and stand. It is a test initially developed by researchers at UFRJ that consists of asking the subject to try to sit and stand in sequence, with the guidance of not using any support, for example the help of the hands or knees to obtain additional balance, leaving thus, that the musculature alone performs the function recruited
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start20 Nov 2020 (estimated)
- Primary completion29 Jan 2021 (estimated)
- Study completion20 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthletesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628403
- Sponsor's protocol ID
- UNIRIO_STUDY
- Status last verified
- Nov 2020
- First submitted
- 26 Oct 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Clinical Interventions for the Management of Late Start Muscular Pain (Doms) in the Post-exercise Recovery Process
- ClinicalTrials.gov ID
- NCT04628403
- Acronym / sponsor ID
- UNIRIO_STUDY
- Conditions
- Athletes
- Keywords
- Lasertherapy, Shockwaves, Massage, Sports Medicine, Athletic Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Study start
- 20 Nov 2020 (estimated)
- Primary completion
- 29 Jan 2021 (estimated)
- Study completion
- 20 Mar 2021 (estimated)
- First posted
- 13 Nov 2020 (actual)
- 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.
Introduction: Late-onset muscle pain (DOMS) is characterized by a type of temporary muscle damage, common after high-intensity exercise. In addition to pain, DOMS clinically generates muscle stiffness, reduced joint range of motion, muscle weakness and reduced peak torque. In this regard, in order to accelerate the recovery of body systems and treat symptoms of DOMS, the management of different types of interventions has been observed, supporting the clinical practice, based on evidence. Objectives: To investigate the effect of different types of clinical interventions for the treatment of DOMS. Material and methods: For the clinical trial, 50 ultramarathon and rowing athletes of both sexes, aged between 18 and 60 years old, will be recruited randomly into four possible groups: control (CG), shock waves (G1) , massage (G2) and laser therapy (G3). The evaluation moments will be as follows: minutes before exercise (M1); immediately after exercise (M2); immediately after applying the recovery technique (M3); and 24 hours after exercise (M4) and the evaluated outcomes will be: pain, psychological aspects, functional test and blood markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| shock waves | Experimental | Device: shock waves |
| massage | Experimental | Other: massage |
| lasertherapy | Experimental | Device: lasertherapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Professional athletes;
- Age over 18 years;
- Both sexes;
- Not having recent injuries
Key exclusion criteria (2 listed)
- Participants who do not complete all the proposed collection moments
- who do not agree to participate will be excluded.
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 |
|---|---|---|
| massageclinical interventions, of mechanophysiological origin for the treatment of symptoms corresponding to DOMS, after exercise | Other | massage |
| lasertherapylasertherapy | Device | lasertherapy |
| shock wavesshock waves | Device | shock waves |
Primary outcome
PAIN
Time frame: 7 days
pain systemic and located in quadriceps, assessed using a visual analog scale (0-10), with 0 indicating no pain and 10 the worst possible pain
SATISFACTION
Time frame: 7 days
Brunel's Mood Scale (BRUMS), with ratings from 0 to 4 where, 0 represents nothing; 1 represents a little, 2 indicates moderately; 3 reports a lot; and 4 corresponds to extremely
1 secondary outcome
MUSCLE STRENGTH
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage, lasertherapy and shock waves in people with Athletes, run by São Paulo State University at 1 site in Brazil.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto L Nahon, Dr (+5521981112880, robertonahon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAIN (time frame: 7 days). The study lists 2 primary outcomes in all. 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 13 Nov 2020.