Forearm Muscle StrainNCT03103048
Application of Different Techniques of Elastic Bandage
A study testing Without bandages, With bandage and With tensioned bandage in people with Forearm Muscle Strain, run by University of Mogi das Cruzes at 1 site in Brazil.
Trial summary
This study will be featured as a randomized controlled. As the dependent variable, was considered isometric grip manual force. As independent variable, the presence or absence of forearm bandage in the fist flexor region of the volunteers. Read more about this study
- Who is it for?
- Ages 18 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Forearm Muscle Strain
- What is being tested?
- Without bandages, With bandage and With tensioned bandage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Apr 2017to 21 Jun 2017
- 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 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Who do not do physical professional activity with upper members;
- Who have no symptom of pain skeletal muscle in the upper members;
- Who have not undergone any type of surgery in the region of the forearm and hand of both members;
- Consent form signed by the volunteer.
Who cannot join
- Having less than 18 years old;
- Having more than 38 years old;
- To present some compromise skeletal muscle in the upper members;
- Who do not want take part in the research;
- Who do not signed consent form as volunteer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Different Techniques of Elastic Bandage: Quantification Electromyographic at the Isometric Effort of Flexor Muscle of Fist
This study will be featured as a randomized controlled. As the dependent variable, was considered isometric grip manual force. As independent variable, the presence or absence of forearm bandage in the fist flexor region of the volunteers.
Read the detailed description
This study is directed to the population of students at the University of Mogi das Cruzes (UMC), and will take part of this study forty volunteers, twenty men and twenty women, aged from eighteen and thirty-eight years old. Will be selected and included volunteers who do not do physical professional activity with upper members, which have no symptom of pain skeletal muscle in the upper members, which have not undergone any type of surgery in the region of the forearm and hand of both members. Will be excluded the volunteers who have injuries, joint injuries, neuromuscular disorder or those who have knowledge of own vestibular or neurological changes. Will also be excluded from study volunteers who do not agree to participate after reading and understanding of informed consent in accordance with resolution 466/12 of the National Ethics Committee and Research. The data acquisition interface will be acquired by an electromyography e a standard of strentgh will maintened in forty Newtons assured by an electronic dynamometer for tests of palmar prehension without and with bandages. The volunteers will not know what kind of intervention will pass. After each application before testing, their both forearms will be covered with a protection. The researcher and the volunteers will not know the tests order.
- Conditions
- Forearm Muscle Strain
- Being tested
- Without bandages, With placebo, With bandage, With tensioned bandage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Without bandagesDiagnostic test
All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore
With placeboDiagnostic test
All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members
With bandageDiagnostic test
All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members
With tensioned bandageDiagnostic test
All volunteers will be held the grasping force measurements with application of bandage with twenty five percent tensioned on the forearm in both upper members
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | The tests will be performed in thirty days, session with lasting 15 minutes each, when all volunteers will be submitted in four measure tests: 1- Without bandages (start); 2 - With placebo; 3 - With bandage; 4 - With tensioned bandage. Receives: Diagnostic Test: Without bandages; Diagnostic Test: With placebo; Diagnostic Test: With bandage; Diagnostic Test: With tensioned bandage |
| Group 2 | Placebo comparator | The tests will be performed in thirty days, session with lasting 15 minutes each, when all volunteers will be submitted in four measure tests: 1- Without bandages; 2 - With placebo (start); 3 - With bandage; 4 - With tensioned bandage. Receives: Diagnostic Test: Without bandages; Diagnostic Test: With placebo; Diagnostic Test: With bandage; Diagnostic Test: With tensioned bandage |
| Group 3 | Active comparator | The tests will be performed in thirty days, session with lasting 15 minutes each, when all volunteers will be submitted in four measure tests: 1- Without bandages; 2 - With placebo; 3 - With bandage (start); 4 - With tensioned bandage. Receives: Diagnostic Test: Without bandages; Diagnostic Test: With placebo; Diagnostic Test: With bandage; Diagnostic Test: With tensioned bandage |
| Group 4 | Active comparator | The tests will be performed in thirty days, session with lasting 15 minutes each, when all volunteers will be submitted in four measure tests: 1- Without bandages; 2 - With placebo; 3 - With bandage; 4 - With tensioned bandage (start). Receives: Diagnostic Test: Without bandages; Diagnostic Test: With placebo; Diagnostic Test: With bandage; Diagnostic Test: With tensioned bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efforts
Thru palmar prehension there will be data acquisition interface by an electromyography e a standard of strentgh maintened in 40 Newtons assured by an electronic dynamometer for tests of palmar prehension, with and without elastic adhesive bandages in the region of flexor muscle of fist.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start3 Apr 2017
- Primary completion8 May 2017
- Study completion21 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forearm Muscle StrainStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mogi das Cruzes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terigi Augusto Scardovelli, University of Mogi das Cruzes
- Investigators
- Terigi A Scardovelli, Ph.D., Principal investigator, University of Mogi das Cruzes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103048
- Sponsor's protocol ID
- CAAE 64513617.3.0000.5497
- Status last verified
- Apr 2017
- First submitted
- 31 Mar 2017
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Different Techniques of Elastic Bandage: Quantification Electromyographic at the Isometric Effort of Flexor Muscle of Fist
- ClinicalTrials.gov ID
- NCT03103048
- Acronym / sponsor ID
- CAAE 64513617.3.0000.5497
- Conditions
- Forearm Muscle Strain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Mogi das CruzesUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 8 May 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 6 Apr 2017 (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.
This study will be featured as a randomized controlled. As the dependent variable, was considered isometric grip manual force. As independent variable, the presence or absence of forearm bandage in the fist flexor region of the volunteers.
Detailed description
This study is directed to the population of students at the University of Mogi das Cruzes (UMC), and will take part of this study forty volunteers, twenty men and twenty women, aged from eighteen and thirty-eight years old. Will be selected and included volunteers who do not do physical professional activity with upper members, which have no symptom of pain skeletal muscle in the upper members, which have not undergone any type of surgery in the region of the forearm and hand of both members. Will be excluded the volunteers who have injuries, joint injuries, neuromuscular disorder or those who have knowledge of own vestibular or neurological changes. Will also be excluded from study volunteers who do not agree to participate after reading and understanding of informed consent in accordance with resolution 466/12 of the National Ethics Committee and Research. The data acquisition interface will be acquired by an electromyography e a standard of strentgh will maintened in forty Newtons assured by an electronic dynamometer for tests of palmar prehension without and with bandages. The volunteers will not know what kind of intervention will pass. After each application before testing, their both forearms will be covered with a protection. The researcher and the volunteers will not know the tests order.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Diagnostic Test: Without bandages, Diagnostic Test: With placebo, Diagnostic Test: With bandage, Diagnostic Test: With tensioned bandageThe tests will be performed in thirty days, session with lasting 15 minutes each, when all volunteers will be submitted in four measure tests: 1- Without bandages (start); 2 - With placebo; 3 - With bandage; 4 - With tensioned bandage. |
| Group 2 | Placebo comparator | Diagnostic Test: Without bandages, Diagnostic Test: With placebo, Diagnostic Test: With bandage, Diagnostic Test: With tensioned bandageThe tests will be performed in thirty days, session with lasting 15 minutes each, when all volunteers will be submitted in four measure tests: 1- Without bandages; 2 - With placebo (start); 3 - With bandage; 4 - With tensioned bandage. |
| Group 3 | Active comparator | Diagnostic Test: Without bandages, Diagnostic Test: With placebo, Diagnostic Test: With bandage, Diagnostic Test: With tensioned bandageThe tests will be performed in thirty days, session with lasting 15 minutes each, when all volunteers will be submitted in four measure tests: 1- Without bandages; 2 - With placebo; 3 - With bandage (start); 4 - With tensioned bandage. |
| Group 4 | Active comparator | Diagnostic Test: Without bandages, Diagnostic Test: With placebo, Diagnostic Test: With bandage, Diagnostic Test: With tensioned bandageThe tests will be performed in thirty days, session with lasting 15 minutes each, when all volunteers will be submitted in four measure tests: 1- Without bandages; 2 - With placebo; 3 - With bandage; 4 - With tensioned bandage (start). |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Who do not do physical professional activity with upper members;
- Who have no symptom of pain skeletal muscle in the upper members;
- Who have not undergone any type of surgery in the region of the forearm and hand of both members;
- Consent form signed by the volunteer.
Key exclusion criteria (5 listed)
- Having less than 18 years old;
- Having more than 38 years old;
- To present some compromise skeletal muscle in the upper members;
- Who do not want take part in the research;
- Who do not signed consent form as volunteer.
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 |
|---|---|---|
| Without bandagesAll volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore | Diagnostic test | Group 1, Group 2, Group 3, Group 4 |
| With placeboAll volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members | Diagnostic test | Group 1, Group 2, Group 3, Group 4 |
| With bandageAll volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members | Diagnostic test | Group 1, Group 2, Group 3, Group 4 |
| With tensioned bandageAll volunteers will be held the grasping force measurements with application of bandage with twenty five percent tensioned on the forearm in both upper members | Diagnostic test | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Efforts
Time frame: 15 minutes
Thru palmar prehension there will be data acquisition interface by an electromyography e a standard of strentgh maintened in 40 Newtons assured by an electronic dynamometer for tests of palmar prehension, with and without elastic adhesive bandages in the region of flexor muscle of fist.
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 18 May 2018.
- Individual participant dataSharing planned: Undecided
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.
Terigi A Scardovelli, Ph.D. principal investigator
University of Mogi das Cruzes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Without bandages, With bandage and With tensioned bandage in people with Forearm Muscle Strain, run by University of Mogi das Cruzes 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 5 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 18 May 2018. 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. Some participants in this study may receive a placebo. 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?
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?
Efforts (time frame: 15 minutes). 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 18 May 2018.