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

Primary Purpose

Ankle Sprain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Grupo LED
Placebo
Sponsored by
Universidade do Vale do Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprain focused on measuring laser, LED, PRICE, pain, edema

Eligibility Criteria

18 Years - 22 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Lasertherapy and Photobiology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LED group

Placebo group

Arm Description

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.

Both volunteers LED group and the placebo group were treated with the same procedure, with the LED device in the placebo group remained off.

Outcomes

Primary Outcome Measures

edema, measured by volumetry
Edema was measured on the first, third and sixth day

Secondary Outcome Measures

pain, measured by the Visual Analogue Pain Scale (VAS) and McGill Pain Questionnaire
Pain was measured on the first, third and sixth day

Full Information

First Posted
April 1, 2015
Last Updated
May 4, 2015
Sponsor
Universidade do Vale do Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT02433964
Brief Title
Evaluation of Therapeutic Effects of LED (627 +/- 10nm) The Initial Phase of the Ankle Sprains Treatment
Official Title
EVALUATION OF THERAPEUTIC EFFECTS OF LED (627 +/- 10nm) THE INITIAL PHASE OF THE ANKLE SPRAINS TREATMENT - A RANDOMIZED PLACEBO-CONTROLLED CLINICAL TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Vale do Paraíba

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain
Keywords
laser, LED, PRICE, pain, edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LED group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Both volunteers LED group and the placebo group were treated with the same procedure, with the LED device in the placebo group remained off.
Intervention Type
Other
Intervention Name(s)
Grupo LED
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
ledterapia off + price
Primary Outcome Measure Information:
Title
edema, measured by volumetry
Description
Edema was measured on the first, third and sixth day
Time Frame
the development of edema in 6 days
Secondary Outcome Measure Information:
Title
pain, measured by the Visual Analogue Pain Scale (VAS) and McGill Pain Questionnaire
Description
Pain was measured on the first, third and sixth day
Time Frame
the evolution of the pain in 6 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno de Moraes Prianti
Organizational Affiliation
Universidade do Vale do Paraíba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lasertherapy and Photobiology Center
City
São José dos Campos
State/Province
São Paulo
ZIP/Postal Code
12244-000
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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