Low Back PainPhase 1NCT02210520
Effect of Ultrasound and Laser in Chronic Low Back Pain: Randomized Double-blinded Controled Trial
A Phase 1 study testing pulsatile ultrasound, continuous ultrasound and laser in people with Low Back Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The low level laser therapy has a better effect in decrease the pain than ultrasound therapeutic. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- pulsatile ultrasound, continuous ultrasound and laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2013to Dec 2014
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult
Who may be able to join
- chronic low back pain
- 3,0 - 7,0 in the visual analogic scale
Who cannot join
- no use of medications
- no other treatment
- without fractures, pregnancy, psychiatric or neurologic disorders, diabetes, amputations
- with diagnostic of low back pain
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
São Lucas College
Porto Velho, Rondõnia, 76800000
Ana Paula A Rubira, Master, 55 069 3211-8082, anapaularubira@hotmail.com
Ana Paula A Rubira, master
About this study
Official title: Effect of Laser and Ultrasound in Pain and Disability in Women With Chronic Non-specific Low Back Pain: Randomized Double-blinded Controled Trial
The low level laser therapy has a better effect in decrease the pain than ultrasound therapeutic.
Read the detailed description
The laser will be applied with the dosimetry 3 J/cm², 2 minutes in 6 points around the back spine, during 4 weeks. Before the women will be evaluate again.
- Conditions
- Low Back Pain
- Being tested
- pulsatile ultrasound, continuous ultrasound, laser
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ultrasoundDevice
1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.
laserDevice
1 W/cm², 2 minutes in 6 points around the back spine
| Study group | Role | What they receive |
|---|---|---|
| laser | Experimental | 3 J/cm², 2 minutes in 6 points around the back spine Receives: Device: pulsatile ultrasound; Device: continuous ultrasound |
| pulsatile ultrasound | Experimental | 1 W/cm², 2 minutes in 6 points around the back spine Receives: Device: continuous ultrasound; Device: 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. Receives: Device: pulsatile ultrasound; Device: laser |
| control | No intervention | no treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Visual Analog Scale
Measured: 4 weeks
Secondary outcomes (2)
Pain quality
McGill questionaire
Measured: 4 weeks
Disability
Roland Morris Questionaire
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 22 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 A Rubira, master, Principal investigator, São Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210520
- Sponsor's protocol ID
- São Lucas College
- Status last verified
- Aug 2014
- First submitted
- 11 Jul 2014
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser and Ultrasound in Pain and Disability in Women With Chronic Non-specific Low Back Pain: Randomized Double-blinded Controled Trial
- ClinicalTrials.gov ID
- NCT02210520
- Acronym / sponsor ID
- São Lucas College
- Conditions
- Low Back Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 6 Aug 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 low level laser therapy has a better effect in decrease the pain than ultrasound therapeutic.
Detailed description
The laser will be applied with the dosimetry 3 J/cm², 2 minutes in 6 points around the back spine, during 4 weeks. Before the women will be evaluate again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| laser | Experimental | Device: pulsatile ultrasound, Device: continuous ultrasound3 J/cm², 2 minutes in 6 points around the back spine |
| pulsatile ultrasound | Experimental | Device: continuous ultrasound, Device: laser1 W/cm², 2 minutes in 6 points around the back spine |
| continuous ultrasound | Experimental | Device: pulsatile ultrasound, Device: laser1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks. |
| control | No intervention | –no treatment. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- chronic low back pain
- 3,0 - 7,0 in the visual analogic scale
Key exclusion criteria (4 listed)
- no use of medications
- no other treatment
- without fractures, pregnancy, psychiatric or neurologic disorders, diabetes, amputations
- with diagnostic of low back pain
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 |
|---|---|---|
| pulsatile ultrasound1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks. | Device | continuous ultrasound, laser |
| continuous ultrasound1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks. | Device | laser, pulsatile ultrasound |
| laser1 W/cm², 2 minutes in 6 points around the back spine | Device | continuous ultrasound, pulsatile ultrasound |
Primary outcome
Pain intensity
Time frame: 4 weeks
Visual Analog Scale
2 secondary outcomes
Pain quality
Time frame: 4 weeks
Disability
Time frame: 4 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
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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 A 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 Phase 1 study testing pulsatile ultrasound, continuous ultrasound and laser in people with 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 2 inclusion and 4 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 6 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2014.