Effect of Ultrasound and Laser in Chronic Low Back Pain: Randomized Double-blinded Controled Trial

August 4, 2014 updated by: Ana Paula Fernandes A. Rubira, University of Sao Paulo General Hospital

Effect of Laser and Ultrasound in Pain and Disability in Women With Chronic Non-specific Low Back Pain: Randomized Double-blinded Controled Trial

The low level laser therapy has a better effect in decrease the pain than ultrasound therapeutic.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The laser will be applied with the dosimetry 3 J/cm², 2 minutes in 6 points around the back spine, during 4 weeks. Before the women will be evaluate again.

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rondõnia
      • Porto Velho, Rondõnia, Brazil, 76800000
        • Recruiting
        • Sâo Lucas College
        • Contact:
        • Principal Investigator:
          • Ana Paula A Rubira, master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • chronic low back pain
  • 3,0 - 7,0 in the visual analogic scale

Exclusion Criteria:

  • no use of medications
  • no other treatment
  • without fractures, pregnancy, psychiatric or neurologic disorders, diabetes, amputations
  • with diagnostic of low back pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: laser
3 J/cm², 2 minutes in 6 points around the back spine
Device: pulsatile ultrasound
1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.
Device: continuous ultrasound
1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.
Experimental: pulsatile ultrasound
1 W/cm², 2 minutes in 6 points around the back spine
Device: continuous ultrasound
1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.
Device: laser
1 W/cm², 2 minutes in 6 points around the back spine
Experimental: continuous ultrasound
1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.
Device: pulsatile ultrasound
1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.
Device: laser
1 W/cm², 2 minutes in 6 points around the back spine
No Intervention: control
no treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 4 weeks
Visual Analog Scale
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain quality
Time Frame: 4 weeks
McGill questionaire
4 weeks
Disability
Time Frame: 4 Weeks
Roland Morris Questionaire
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Ana Paula A Rubira, master, Sao Paulo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 6, 2014

Study Record Updates

Last Update Posted (Estimate)

August 6, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • São Lucas College

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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