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Clinical Trials/NCT02210520
NCT02210520UnknownPhase 1

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

University of Sao Paulo General Hospital1 site in 1 country22 target enrollmentStarted: October 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Enrollment
22
Locations
1
Primary Endpoint
Pain intensity

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

laser

Experimental

3 J/cm², 2 minutes in 6 points around the back spine

Intervention: pulsatile ultrasound (Device)

laser

Experimental

3 J/cm², 2 minutes in 6 points around the back spine

Intervention: continuous ultrasound (Device)

pulsatile ultrasound

Experimental

1 W/cm², 2 minutes in 6 points around the back spine

Intervention: continuous ultrasound (Device)

pulsatile ultrasound

Experimental

1 W/cm², 2 minutes in 6 points around the back spine

Intervention: laser (Device)

continuous ultrasound

Experimental

1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.

Intervention: pulsatile ultrasound (Device)

continuous ultrasound

Experimental

1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.

Intervention: laser (Device)

control

No Intervention

no treatment.

Outcomes

Primary Outcomes

Pain intensity

Time Frame: 4 weeks

Visual Analog Scale

Secondary Outcomes

  • Disability(4 Weeks)
  • Pain quality(4 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ana Paula Fernandes A. Rubira

Master

University of Sao Paulo General Hospital

Study Sites (1)

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