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

Ankle Sprain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433964
• Other study ID #: University of Vale of Paraíba
• Status: Completed
• Phase: N/A
• First received: April 1, 2015
• Last updated: May 4, 2015
• Start date: May 2012
• Est. completion date: November 2012

Study information

• Verified date: April 2015
• Source: Universidade do Vale do Paraíba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 22 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain

Intervention

Other:
• Grupo LED

• Placebo
ledterapia off + price

Locations

Country	Name	City	State
Brazil	Lasertherapy and Photobiology Center	São José dos Campos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	edema, measured by volumetry	Edema was measured on the first, third and sixth day	the development of edema in 6 days	No
Secondary	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	No