Chronic Low Back PainNCT02150096
Laser and Therapeutic Ultrasound in the Management of the Chronic Non-specific Low Back Pain
A study testing continuous ultrasound group, pulsed ultrasound group and low level laser therapy group in people with Chronic Low Back Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- continuous ultrasound group, pulsed ultrasound group and low level laser therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-specific chronic low back pain
- moderate pain
- eutrophics women
Who cannot join
- disk herniation
- cardiac diseases
- psychiatrics diseases
- endocrinous diseases
- fractures of the spine
- fractures of lower members
Show all 13Show fewer
- diabetics
- dental emergency
- local infections
- local non sensibility
- analgesics and anti-inflammatories in use
- neurologic diseases
- pregnancy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sâo Lucas College
Porto Velho, Rondônia, 76804070
ANA PAULA RUBIRA, MASTER, 55 069 32118082, anapaularubira@hotmail.com
MARCELO RUBIRA, DOCTOR, 55 069 92289889, marcelorubira@hotmail.com
About this study
Official title: Laser and and Ultrasound Effect on Pain and Disability in Women With Chronic Non-specific Low Back Pain: a Randomized Controlled Trial
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.
- Conditions
- Chronic Low Back Pain
- Being tested
- continuous ultrasound group, pulsed ultrasound group, low level laser therapy group
- Keywords
- chronic non-specific low back pain, clinical trial, disability, women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous ultrasound groupOther
Also called Sonopulse III, Ibramed, 1 MHz and 3 MHz of frequency
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 groupOther
Also called Sonopulse III, Ibramed, 1 MHz and 3 MHz of frequency
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 groupOther
Also called Laserpulse, Ibramed, 904 nm
the group will be treated with 3 J 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: pulsed ultrasound group; Other: 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 Receives: Other: continuous ultrasound group; Other: 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 Receives: Other: continuous ultrasound group; Other: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evaluation
The visual analogic scale will be used for evaluate the pain.
Measured: The pain will be evaluate before and after 25 days of the treatment
Secondary outcomes (1)
Disability evaluation
The Roland Morris questionaire will be used to evaluate the disability.
Measured: The disability will be evaluate before and after 25 days of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2014
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Paula Fernandes A. Rubira, University of Sao Paulo General Hospital
- Investigators
- ANA PAULA RUBIRA, MASTER, Principal investigator, SÃO PAULO UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150096
- Sponsor's protocol ID
- CEP 390/10
- Status last verified
- May 2014
- First submitted
- 7 Mar 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31847915de 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.
PubMed 31619287
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser and and Ultrasound Effect on Pain and Disability in Women With Chronic Non-specific Low Back Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02150096
- Acronym / sponsor ID
- CEP 390/10
- Conditions
- Chronic Low Back Pain
- Keywords
- chronic non-specific low back pain, clinical trial, disability, women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (estimated)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Continuous ultrasound group | Active comparator | Other: pulsed ultrasound group, Other: low level laser therapy groupthe 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 | Active comparator | Other: continuous ultrasound group, Other: low level laser therapy groupthe 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 | Active comparator | Other: continuous ultrasound group, Other: pulsed ultrasound groupthe group will be treated with 3J during 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine |
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- non-specific chronic low back pain
- moderate pain
- eutrophics women
Key exclusion criteria (13 listed)
- disk herniation
- cardiac diseases
- psychiatrics diseases
- endocrinous diseases
- fractures of the spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous ultrasound groupAlso: Sonopulse III, Ibramed, 1 MHz and 3 MHz of frequencythe 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 group, low level laser therapy group |
| pulsed ultrasound groupAlso: Sonopulse III, Ibramed, 1 MHz and 3 MHz of frequencythe 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 group, low level laser therapy group |
| low level laser therapy groupAlso: Laserpulse, Ibramed, 904 nmthe group will be treated with 3 J 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine | Other | Continuous ultrasound group, Pulsed ultrasound group |
Primary outcome
Pain evaluation
Time frame: The pain will be evaluate before and after 25 days of the treatment
The visual analogic scale will be used for evaluate the pain.
1 secondary outcome
Disability evaluation
Time frame: The disability will be evaluate before and after 25 days of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
- Derived from this study: PubMed 31847915Rubira 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.
- Derived from this study: PubMed 31619287de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANA PAULA RUBIRA, MASTER principal investigator
SÃO PAULO UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous ultrasound group, pulsed ultrasound group and low level laser therapy group in people with Chronic Low Back Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANA PAULA F A RUBIRA, Ms (55 069 92070778, anapaularubira@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain evaluation (time frame: The pain will be evaluate before and after 25 days of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02150096, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2014.