Laser and Therapeutic Ultrasound in the Management of the Chronic Non-specific Low Back Pain

NCT ID: NCT02150096

Last Updated: 2014-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-07-31

Brief Summary

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The objective of this study is evaluate the laser and ultrasound effect on pain and disability in women with non-specific chronic low back pain.

Detailed Description

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Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Continuous ultrasound group

the group will be treated with 1,5 W/cm² 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine

Group Type ACTIVE_COMPARATOR

pulsed ultrasound group

Intervention Type OTHER

the group will be treated with 1,5 W/cm² 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine

low level laser therapy group

Intervention Type OTHER

the group will be treated with 3 J 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine

Pulsed ultrasound group

the group will be treated with 1,5 W/cm² 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine

Group Type ACTIVE_COMPARATOR

continuous ultrasound group

Intervention Type OTHER

the group will be treated with 1,5 W/cm² 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine

low level laser therapy group

Intervention Type OTHER

the group will be treated with 3 J 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine

low level laser therapy group

the group will be treated with 3J during 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine

Group Type ACTIVE_COMPARATOR

continuous ultrasound group

Intervention Type OTHER

the group will be treated with 1,5 W/cm² 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine

pulsed ultrasound group

Intervention Type OTHER

the group will be treated with 1,5 W/cm² 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine

control group

group of women no treated, only evaluated in two moments and this group will be compared with orthers: laser, pulsed ultrasound and continuous ultrasound.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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continuous ultrasound group

the group will be treated with 1,5 W/cm² 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine

Intervention Type OTHER

pulsed ultrasound group

the group will be treated with 1,5 W/cm² 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine

Intervention Type OTHER

low level laser therapy group

the group will be treated with 3 J 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine

Intervention Type OTHER

Other Intervention Names

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Sonopulse III Ibramed 1 MHz and 3 MHz of frequency Sonopulse III Ibramed 1 MHz and 3 MHz of frequency Laserpulse Ibramed 904 nm

Eligibility Criteria

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Inclusion Criteria

* non-specific chronic low back pain
* moderate pain
* eutrophics women

Exclusion Criteria

* disk herniation
* cardiac diseases
* psychiatrics diseases
* endocrinous diseases
* fractures of the spine
* fractures of lower members
* diabetics
* dental emergency
* local infections
* local non sensibility
* analgesics and anti-inflammatories in use
* neurologic diseases
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ana Paula Fernandes A. Rubira

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ANA PAULA RUBIRA, MASTER

Role: PRINCIPAL_INVESTIGATOR

SÃO PAULO UNIVERSITY

Locations

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Sâo Lucas College

Porto Velho, Rondônia, Brazil

Site Status

Countries

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Brazil

Central Contacts

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ANA PAULA F A RUBIRA, Ms

Role: CONTACT

55 069 92070778

Facility Contacts

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ANA PAULA RUBIRA, MASTER

Role: primary

55 069 32118082

MARCELO RUBIRA, DOCTOR

Role: backup

55 069 92289889

References

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Rubira APFA, Rubira MC, Rubira LA, Comachio J, Magalhaes MO, Marques AP. Comparison of the effects of low-level laser and pulsed and continuous ultrasound on pain and physical disability in chronic non-specific low back pain: a randomized controlled clinical trial. Adv Rheumatol. 2019 Dec 17;59(1):57. doi: 10.1186/s42358-019-0099-z.

Reference Type DERIVED
PMID: 31847915 (View on PubMed)

de Resende Guimaraes MFB, Rodrigues CEM, Gomes KWP, Machado CJ, Brenol CV, Krampe SF, de Andrade NPB, Kakehasi AM. High prevalence of obesity in rheumatoid arthritis patients: association with disease activity, hypertension, dyslipidemia and diabetes, a multi-center study. Adv Rheumatol. 2019 Oct 16;59(1):44. doi: 10.1186/s42358-019-0089-1.

Reference Type DERIVED
PMID: 31619287 (View on PubMed)

Other Identifiers

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CEP 390/10

Identifier Type: -

Identifier Source: org_study_id

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