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

NCT02433964 | Completed

• 1 other identifier: University of Vale of Paraíba
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Sprain

Keywords

laser; LED; PRICE; pain; edema

Outcome Measures

Primary Outcomes (1)

• edema, measured by volumetry

  Edema was measured on the first, third and sixth day

  the development of edema in 6 days

Secondary Outcomes (1)

• pain, measured by the Visual Analogue Pain Scale (VAS) and McGill Pain Questionnaire

  the evolution of the pain in 6 days

Study Arms (2)

LED group

EXPERIMENTAL

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 group

PLACEBO COMPARATOR

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

Interventions

Grupo LED OTHER

LED group

Placebo OTHER

ledterapia off + price

Placebo group

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade do Vale do Paraíba: lead

Study Sites (1)

Lasertherapy and Photobiology Center

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

Location

MeSH Terms

Conditions

Ankle Injuries; Pain; Edema

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bruno de Moraes Prianti

  Universidade do Vale do Paraíba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: May 5, 2015
• Study Start: May 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 5, 2015

Record last verified: 2015-04

Locations

BR (1)