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

NCT ID: NCT02433964

Last Updated: 2015-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-11-30

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.

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.

Conditions

Ankle Sprain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Grupo LED

Intervention Type: OTHER

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

ledterapia off + price

Interventions

Grupo LED

Intervention Type: OTHER

Placebo

ledterapia off + price

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Universidade do Vale do Paraíba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno de Moraes Prianti

Role: PRINCIPAL_INVESTIGATOR

Universidade do Vale do Paraíba

Locations

Lasertherapy and Photobiology Center

São José dos Campos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

University of Vale of Paraíba

Identifier Type: -

Identifier Source: org_study_id