NCT02150096

Brief Summary

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.

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
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 7, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

Same day

First QC Date

March 7, 2014

Last Update Submit

May 25, 2014

Conditions

Chronic Low Back Pain

Keywords

chronic non-specific low back painclinical trialdisabilitywomen

Outcome Measures

Primary Outcomes (1)

  • Pain evaluation

    The visual analogic scale will be used for evaluate the pain.

    The pain will be evaluate before and after 25 days of the treatment

Secondary Outcomes (1)

  • Disability evaluation

    The disability will be evaluate before and after 25 days of the treatment

Other Outcomes (1)

  • Multidimensional evaluation of pain

    The multidimensional evaluation of pain will be realized before and after 25 days of the treatment

Study Arms (4)

Continuous ultrasound group

ACTIVE COMPARATOR

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

Other: pulsed ultrasound groupOther: low level laser therapy group

Pulsed ultrasound group

ACTIVE COMPARATOR

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

Other: continuous ultrasound groupOther: low level laser therapy group

low level laser therapy group

ACTIVE COMPARATOR

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

Other: continuous ultrasound groupOther: pulsed ultrasound group

control group

NO INTERVENTION

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

Interventions

continuous ultrasound groupOTHER

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

Also known as: Sonopulse III, Ibramed, 1 MHz and 3 MHz of frequency
Pulsed ultrasound grouplow level laser therapy group
pulsed ultrasound groupOTHER

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

Also known as: Sonopulse III, Ibramed, 1 MHz and 3 MHz of frequency
Continuous ultrasound grouplow level laser therapy group
low level laser therapy groupOTHER

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

Also known as: Laserpulse, Ibramed, 904 nm
Continuous ultrasound groupPulsed ultrasound group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sâo Lucas College

Porto Velho, Rondônia, 76804070, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 31847915DERIVED

  • 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.

    PMID: 31619287DERIVED

Study Officials

  • ANA PAULA RUBIRA, MASTER

    SÃO PAULO UNIVERSITY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ANA PAULA F A RUBIRA, Ms

CONTACT

55 069 92070778anapaularubira@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 7, 2014

First Posted

May 29, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations

BR(1)