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

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

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.

Study Overview

• Status: Completed
• Conditions: Ankle Sprain
• Intervention / Treatment: Other: Grupo LED; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São José dos Campos, São Paulo, Brazil, 12244-000
      • Lasertherapy and Photobiology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 22 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
edema, measured by volumetry	Edema was measured on the first, third and sixth day	the development of edema in 6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain, measured by the Visual Analogue Pain Scale (VAS) and McGill Pain Questionnaire	Pain was measured on the first, third and sixth day	the evolution of the pain in 6 days

Collaborators and Investigators

• Sponsor: Universidade do Vale do Paraíba
• Investigators: Principal Investigator: Bruno de Moraes Prianti, Universidade do Vale do Paraíba

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: April 1, 2015
• First Submitted That Met QC Criteria: May 4, 2015
• First Posted (Estimate): May 5, 2015

Study Record Updates

• Last Update Posted (Estimate): May 5, 2015
• Last Update Submitted That Met QC Criteria: May 4, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: pain; edema; laser; LED; PRICE
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: University of Vale of Paraíba