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

Primary Purpose

Low Back Pain

Status

Unknown status

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

pulsatile ultrasound

continuous ultrasound

laser

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

São Lucas CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

laser

pulsatile ultrasound

continuous ultrasound

control

Arm Description

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

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

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

no treatment.

Outcomes

Primary Outcome Measures

Pain intensity

Visual Analog Scale

Secondary Outcome Measures

Pain quality

McGill questionaire

Disability

Roland Morris Questionaire

Full Information

NCT ID

NCT02210520

First Posted

July 11, 2014

Last Updated

August 4, 2014

Sponsor

University of Sao Paulo General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02210520

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

laser

Arm Type

Experimental

Arm Description

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

Arm Title

pulsatile ultrasound

Arm Type

Experimental

Arm Description

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

Arm Title

continuous ultrasound

Arm Type

Experimental

Arm Description

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

Arm Title

control

Arm Type

No Intervention

Arm Description

no treatment.

Intervention Type

Device

Intervention Name(s)

pulsatile ultrasound

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

continuous ultrasound

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

laser

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain intensity

Description

Visual Analog Scale

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Pain quality

Description

McGill questionaire

Time Frame

4 weeks

Title

Disability

Description

Roland Morris Questionaire

Time Frame

4 Weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana Paula A Rubira, master

Organizational Affiliation

São Paulo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

São Lucas College

City

Porto Velho

State/Province

Rondõnia

ZIP/Postal Code

76800000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ana Paula A Rubira, Master

Phone

55 069 3211-8082

anapaularubira@hotmail.com

First Name & Middle Initial & Last Name & Degree

Ana Paula A Rubira, master

12. IPD Sharing Statement

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

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