Low Back PainNCT01556295
Gesture Behavior and Knowledge on Low Back Pain Among Nurses
An observational study of Low Back Pain, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The aim of the proposed study is to evaluate knowledge on low back pain and gesture behavior among nurses with low back pain using validated measures and compare the findings to those from nurses without back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Apr 2013
- Phase
- Observational
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Nurses with non-specific low back pain and healthy nurses
Who may be able to join
- Non-specific chronic low back pain,
- Performance in the hospital sector (hospitals, emergency rooms and/or intensive care units,
- Hourly load of at least 6 hours per day,
- Low back pain on most days in the last three months,
- Pain greater than 3 cm in visual analog scale (VAS).
Who cannot join
- Dispute,
- Previous surgery of the spine,
- Pregnant.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
HIsa Costa Morimoto
São Paulo, São Paulo
Hisa Morimoto, PT, 551145821770, hisamorimoto@gmail.com
Jamil Natour, MD, PHD, 551155764239, jnatour@unifesp.br
About this study
Official title: Assessment of Gesture Behavior and Knowledge on Low Back Pain Among Nurses
The aim of the proposed study is to evaluate knowledge on low back pain and gesture behavior among nurses with low back pain using validated measures and compare the findings to those from nurses without back pain.
Read the detailed description
A controlled, cross-sectional study will be carried out with 100 nurses (50 with low back pain and 50 without low back pain). The following assessment measures will be employed: Visual analogue scale (VAS) for pain, Gesture Behavior Test (GBT), Low Back Pain Knowledge Questionnaire (LKQ), Roland Morris Questionnaire and the SF-36.
- Conditions
- Low Back Pain
- Keywords
- Nurses, Low back pain, Gesture behavior, Knowlegde
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gesture behavior
Measured: One week
Secondary outcomes (4)
Knowledge among low back pain
Measured: One week
Roland Morris Questionnaire
Used health status measure for low back pain
Measured: One week
SF-36
Quality of life by SF-36
Measured: One week
Visual analogue scale (VAS) for pain
Evaluation pain
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2012 (estimated)
- Study completionApr 2013 (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 Low Back PainStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisa Costa Morimoto, Federal University of São Paulo
- Investigators
- Hisa Morimoto, PT, Principal investigator, Federal University of São PauloAnamaria Jones, PT, PHD, Study director, Federal University of São PauloJamil Natour, MD, PHD, Study chair, Division of Rheumatology, Federal University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556295
- Sponsor's protocol ID
- 1586/08
- Status last verified
- Mar 2012
- First submitted
- 13 Mar 2012
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Furtado R, Jones A, Furtado RN, Jennings F, Natour J. Validation of the Brazilian-Portuguese version of the Gesture Behavior Test for patients with non-specific chronic low back pain. Clinics (Sao Paulo). 2009;64(2):83-90. doi: 10.1590/s1807-59322009000200004.
PubMed 19219312Morimoto HC, Jones A, Natour J. Assessment of gesture behavior and knowledge on low back pain among nurses. Adv Rheumatol. 2018 Sep 7;58(1):27. doi: 10.1186/s42358-018-0029-5.
PubMed 30657083
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Gesture Behavior and Knowledge on Low Back Pain Among Nurses
- ClinicalTrials.gov ID
- NCT01556295
- Acronym / sponsor ID
- 1586/08
- Conditions
- Low Back Pain
- Keywords
- Nurses, Low back pain, Gesture behavior, Knowlegde
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 16 Mar 2012 (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 aim of the proposed study is to evaluate knowledge on low back pain and gesture behavior among nurses with low back pain using validated measures and compare the findings to those from nurses without back pain.
Detailed description
A controlled, cross-sectional study will be carried out with 100 nurses (50 with low back pain and 50 without low back pain). The following assessment measures will be employed: Visual analogue scale (VAS) for pain, Gesture Behavior Test (GBT), Low Back Pain Knowledge Questionnaire (LKQ), Roland Morris Questionnaire and the SF-36.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | – |
| Control | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Nurses with non-specific low back pain and healthy nurses
Key inclusion criteria (5 listed)
- Non-specific chronic low back pain,
- Performance in the hospital sector (hospitals, emergency rooms and/or intensive care units,
- Hourly load of at least 6 hours per day,
- Low back pain on most days in the last three months,
- Pain greater than 3 cm in visual analog scale (VAS).
Key exclusion criteria (3 listed)
- Dispute,
- Previous surgery of the spine,
- Pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gesture behavior
Time frame: One week
4 secondary outcomes
Knowledge among low back pain
Time frame: One week
Roland Morris Questionnaire
Time frame: One week
SF-36
Time frame: One week
Visual analogue scale (VAS) for pain
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
- Background: PubMed 19219312Furtado R, Jones A, Furtado RN, Jennings F, Natour J. Validation of the Brazilian-Portuguese version of the Gesture Behavior Test for patients with non-specific chronic low back pain. Clinics (Sao Paulo). 2009;64(2):83-90. doi: 10.1590/s1807-59322009000200004.
- Derived from this study: PubMed 30657083Morimoto HC, Jones A, Natour J. Assessment of gesture behavior and knowledge on low back pain among nurses. Adv Rheumatol. 2018 Sep 7;58(1):27. doi: 10.1186/s42358-018-0029-5.
- low back pain with rehabilitationLink provided by the sponsor.
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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.
Hisa Morimoto, PT principal investigator
Federal University of São Paulo
Anamaria Jones, PT, PHD study director
Federal University of São Paulo
Jamil Natour, MD, PHD study chair
Division of Rheumatology, Federal University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Federal University of São Paulo 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 5 inclusion and 3 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 19 Mar 2012. 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 Hisa Morimoto, PT (551145821770, hisamorimoto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gesture behavior (time frame: One week). 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 NCT01556295, 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 19 Mar 2012.