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Evaluation of Therapeutic Effects of LED (627 +/- 10nm) The Initial Phase of the Ankle Sprains Treatment

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ClinicalTrials.gov Identifier: NCT02433964
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):
Universidade do Vale do Paraíba

Brief Summary:
The purpose of this study is to evaluate the therapeutic effects of the LED (627 +/- 10 nm) with respect to the localized pain and local swelling of ankle sprains in the initial phase.

Condition or disease Intervention/treatment Phase
Ankle Sprain Other: Grupo LED Other: Placebo Not Applicable

Detailed Description:
A variety of therapies for the treatment of sprains has emerged as they occur advances in technological applications. Therapy with coherent and non-coherent light is a treatment modality for a variety of musculoskeletal injuries. The main benefits certificates for phototherapy are the reduction of nociceptive processes, tissue remodeling, among others. The aim of the present paper is to analyze the changes caused by the use of LED (627 +/- 10 nm) with an energy density of 10 J / cm2 in 40 subjects divided into two groups (placebo and LED). All volunteers participating in this study had ankle inversion sprain grade II treated with the price technique. The study was performed in six days. And the results were verified by review of all individuals, through the Visual Analogue Scale (VAS) of pain, McGill Pain Questionnaire and Titrimetry. Measurements were performed at first, third and sixth day's of treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EVALUATION OF THERAPEUTIC EFFECTS OF LED (627 +/- 10nm) THE INITIAL PHASE OF THE ANKLE SPRAINS TREATMENT - A RANDOMIZED PLACEBO-CONTROLLED CLINICAL TRIAL
Study Start Date : May 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: LED group
Treated by a device LED - LED: power 60mW, 627nm wavelength ± 10nm and 1,3cm2 beam output. The energy density used was 10J / cm2 with time of 2 minutes and 47 seconds per flash of the beam, which is unique for each ten points in the lateral region of the ankle edema. The volunteers underwent previous cleaning application points with cotton soaked in 70% alcohol, positioned for high stretcher in the supine position and wearing goggles. The LED was applied in a timely manner, wherein the skin contact surfasse at an angle of 90 °, the ten points were irradiated in a 1cm2 area selected by a single investigator. One session was performed every 24 hours for six consecutive days. Ice applications were made associated with semi-rigid compression bandage, with the patient lying supine and the affected limb in elevation under a foam wedge in the same period.
Other: Grupo LED
Placebo Comparator: Placebo group
Both volunteers LED group and the placebo group were treated with the same procedure, with the LED device in the placebo group remained off.
Other: Placebo
ledterapia off + price




Primary Outcome Measures :
  1. edema, measured by volumetry [ Time Frame: the development of edema in 6 days ]
    Edema was measured on the first, third and sixth day


Secondary Outcome Measures :
  1. pain, measured by the Visual Analogue Pain Scale (VAS) and McGill Pain Questionnaire [ Time Frame: the evolution of the pain in 6 days ]
    Pain was measured on the first, third and sixth day



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Ages Eligible for Study:   18 Years to 22 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active individuals
  • With medical referral
  • With clinical diagnosis of inversion sprain grade II
  • The day he suffered the injury
  • Without prescriptions

Exclusion Criteria:

  • Individuals who had previous trauma and orthopedic disorders such as fractures, tendinopathy, previous surgical procedure
  • Other systemic diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433964


Locations
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Brazil
Lasertherapy and Photobiology Center
São José dos Campos, São Paulo, Brazil, 12244-000
Sponsors and Collaborators
Universidade do Vale do Paraíba
Investigators
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Principal Investigator: Bruno de Moraes Prianti Universidade do Vale do Paraíba

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Responsible Party: Universidade do Vale do Paraíba
ClinicalTrials.gov Identifier: NCT02433964     History of Changes
Other Study ID Numbers: University of Vale of Paraíba
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: April 2015
Keywords provided by Universidade do Vale do Paraíba:
laser
LED
PRICE
pain
edema
Additional relevant MeSH terms:
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Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries