Application of Different Techniques of Elastic Bandage

• ClinicalTrials.gov Identifier: NCT03103048
• Recruitment Status: Completed
• First Posted: April 6, 2017
• Last Update Posted: May 18, 2018
• Sponsor: University of Mogi das Cruzes
• Information provided by (Responsible Party): Terigi Augusto Scardovelli, University of Mogi das Cruzes

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Forearm Muscle Strain	Diagnostic Test: Without bandages; Diagnostic Test: With placebo; Diagnostic Test: With bandage; Diagnostic Test: With tensioned bandage	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• Official Title: Application of Different Techniques of Elastic Bandage: Quantification Electromyographic at the Isometric Effort of Flexor Muscle of Fist
• Actual Study Start Date: April 3, 2017
• Actual Primary Completion Date: May 8, 2017
• Actual Study Completion Date: June 21, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Group 1; 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.	Diagnostic Test: Without bandages; All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore; Diagnostic Test: With placebo; All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members; Diagnostic Test: With bandage; All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members; Diagnostic Test: With tensioned bandage; 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
Placebo Comparator: Group 2; 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.	Diagnostic Test: Without bandages; All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore; Diagnostic Test: With placebo; All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members; Diagnostic Test: With bandage; All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members; Diagnostic Test: With tensioned bandage; 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
Active Comparator: Group 3; 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.	Diagnostic Test: Without bandages; All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore; Diagnostic Test: With placebo; All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members; Diagnostic Test: With bandage; All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members; Diagnostic Test: With tensioned bandage; 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
Active Comparator: Group 4; 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).	Diagnostic Test: Without bandages; All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore; Diagnostic Test: With placebo; All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members; Diagnostic Test: With bandage; All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members; Diagnostic Test: With tensioned bandage; 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

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 38 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

Brazil

Terigi Augusto Scardovelli

Mogi Das Cruzes, São Paulo, Brazil, 08615120

Sponsors and Collaborators

University of Mogi das Cruzes

Investigators

• Principal Investigator: Terigi A Scardovelli, Ph.D.; University of Mogi das Cruzes

More Information

• Responsible Party: Terigi Augusto Scardovelli, Principal Investigator, University of Mogi das Cruzes
• ClinicalTrials.gov Identifier: NCT03103048
• Other Study ID Numbers: CAAE 64513617.3.0000.5497
• First Posted: April 6, 2017
• Last Update Posted: May 18, 2018
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Sprains and Strains; Wounds and Injuries