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Completed

NCT Number: NCT02433964

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

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.

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Key information

Age range

18 year–22 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Lasertherapy and Photobiology Center

São José dos Campos, São Paulo, 12244-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Grupo LED

Other

Placebo

Other

ledterapia off + price

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidade do Vale do Paraíba

Other

Registry information

Official study title

EVALUATION OF THERAPEUTIC EFFECTS OF LED (627 +/- 10nm) THE INITIAL PHASE OF THE ANKLE SPRAINS TREATMENT - A RANDOMIZED PLACEBO-CONTROLLED CLINICAL TRIAL

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 5, 2015
Registry last updated
May 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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