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

Primary Purpose

Chronic Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
continuous ultrasound group
pulsed ultrasound group
low level laser therapy group
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring chronic non-specific low back pain, clinical trial, disability, women

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Sâo Lucas College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Continuous ultrasound group

Pulsed ultrasound group

low level laser therapy group

control group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Disability evaluation
The Roland Morris questionaire will be used to evaluate the disability.

Full Information

First Posted
March 7, 2014
Last Updated
May 25, 2014
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02150096
Brief Title
Laser and Therapeutic Ultrasound in the Management of the Chronic Non-specific Low Back Pain
Official Title
Laser and and Ultrasound Effect on Pain and Disability in Women With Chronic Non-specific Low Back Pain: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
July 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 objective of this study is evaluate the laser and ultrasound effect on pain and disability in women with non-specific chronic low back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
chronic non-specific low back pain, clinical trial, disability, women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous ultrasound group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Pulsed ultrasound group
Arm Type
Active Comparator
Arm Description
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
Arm Title
low level laser therapy group
Arm Type
Active Comparator
Arm Description
the group will be treated with 3J during 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine
Arm Title
control group
Arm Type
No Intervention
Arm Description
group of women no treated, only evaluated in two moments and this group will be compared with orthers: laser, pulsed ultrasound and continuous ultrasound.
Intervention Type
Other
Intervention Name(s)
continuous ultrasound group
Other Intervention Name(s)
Sonopulse III, Ibramed, 1 MHz and 3 MHz of frequency
Intervention Description
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
Intervention Name(s)
pulsed ultrasound group
Other Intervention Name(s)
Sonopulse III, Ibramed, 1 MHz and 3 MHz of frequency
Intervention Description
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
Intervention Name(s)
low level laser therapy group
Other Intervention Name(s)
Laserpulse, Ibramed, 904 nm
Intervention Description
the group will be treated with 3 J 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine
Primary Outcome Measure Information:
Title
Pain evaluation
Description
The visual analogic scale will be used for evaluate the pain.
Time Frame
The pain will be evaluate before and after 25 days of the treatment
Secondary Outcome Measure Information:
Title
Disability evaluation
Description
The Roland Morris questionaire will be used to evaluate the disability.
Time Frame
The disability will be evaluate before and after 25 days of the treatment
Other Pre-specified Outcome Measures:
Title
Multidimensional evaluation of pain
Description
The McGill questionaire will be used for the evaluation.
Time Frame
The multidimensional evaluation of pain will be realized before and after 25 days of the treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ANA PAULA F A RUBIRA, Ms
Phone
55 069 92070778
Email
anapaularubira@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANA PAULA RUBIRA, MASTER
Organizational Affiliation
SÃO PAULO UNIVERSITY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sâo Lucas College
City
Porto Velho
State/Province
Rondônia
ZIP/Postal Code
76804070
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANA PAULA RUBIRA, MASTER
Phone
55 069 32118082
Email
anapaularubira@hotmail.com
First Name & Middle Initial & Last Name & Degree
MARCELO RUBIRA, DOCTOR
Phone
55 069 92289889
Email
marcelorubira@hotmail.com
First Name & Middle Initial & Last Name & Degree
ANA PAULA RUBIRA, MASTER

12. IPD Sharing Statement

Citations:
PubMed Identifier
31847915
Citation
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.
Results Reference
derived
PubMed Identifier
31619287
Citation
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.
Results Reference
derived

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

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