NCT02210520

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for phase_1 low-back-pain

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

1.2 years

First QC Date

July 11, 2014

Last Update Submit

August 4, 2014

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Visual Analog Scale

    4 weeks

Secondary Outcomes (2)

  • Pain quality

    4 weeks

  • Disability

    4 Weeks

Study Arms (4)

laser

EXPERIMENTAL

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

Device: pulsatile ultrasoundDevice: continuous ultrasound

pulsatile ultrasound

EXPERIMENTAL

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

Device: continuous ultrasoundDevice: laser

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.

Device: pulsatile ultrasoundDevice: laser

control

NO INTERVENTION

no treatment.

Interventions

pulsatile ultrasoundDEVICE

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

continuous ultrasoundlaser
continuous ultrasoundDEVICE

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

laserpulsatile ultrasound
laserDEVICE

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

continuous ultrasoundpulsatile ultrasound

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

São Lucas College

Porto Velho, Rondõnia, 76800000, Brazil

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Lasers

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Ana Paula A Rubira, master

    São Paulo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master

Study Record Dates

First Submitted

July 11, 2014

First Posted

August 6, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 6, 2014

Record last verified: 2014-08

Locations

BR(1)