Abnormally Decreased Muscle ContractionNCT01488760
Abdominal Wall Evaluation in Low Back Pain
An observational study of Abnormally Decreased Muscle Contraction, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study was to evaluate feed-forward contraction of the transversus abdominis and thickness of the transversus abdominis, obliquus internus, and obliquus externus during calm and standardized respiration in low back pain patients and pain-free subjects. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abnormally Decreased Muscle Contraction
- How many people
- 39 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2009to Nov 2010
- 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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Community sample
Who may be able to join
- For the low back pain group: women with history of non-specific chronic low back pain for more than three months
- For the pain-free group: pain-free women
Who cannot join
- For both groups were: pregnancy, neurological condition, obesity (body mass index: BMI >30), or previous spine or abdominal surgery.
- For the low back pain group: rheumatology diseases other than low back pain.
- For the pain-free group: any rheumatology disease.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo, Brazil
São Paulo, São Paulo, 05403-000
About this study
Official title: Deep Abdominal Wall Muscle Dysfunction During Calm Respiration in Chronic Low Back Pain Patients
The purpose of this study was to evaluate feed-forward contraction of the transversus abdominis and thickness of the transversus abdominis, obliquus internus, and obliquus externus during calm and standardized respiration in low back pain patients and pain-free subjects.
Read the detailed description
Low back pain patients have alterations in abdominal wall function, especially in the feed-forward activation of transversus muscle during limbs movements. However, there are no reports on the abdominal function in low back pain patients during physiological respiratory movement.
- Conditions
- Abnormally Decreased Muscle Contraction
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 |
|---|---|---|
| Nineteen women with low back pain | Not described | |
| Twenty pain-free women | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startDec 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormally Decreased Muscle ContractionStudies 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clarice Tanaka, PhD, Principal investigator, Full Professor - Department of Physical Therapy, Communication Science & Disorders, Occupational Therapy, Faculty of Medicine - USPPatricia R Patarro, Study chair, Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo, BrazilRenato A Sernik, Study chair, Institute of Radiology, School of Medicine: University of São Paulo, BrazilDébora M Meira, Study chair, Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo, BrazilAmérica C Fracini, Study chair, Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo, BrazilCássio M Siqueira, Study chair, Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488760
- Sponsor's protocol ID
- FRACINI
- Status last verified
- Dec 2011
- First submitted
- 6 Dec 2011
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Abdominal Wall Muscle Dysfunction During Calm Respiration in Chronic Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT01488760
- Acronym / sponsor ID
- FRACINI
- Conditions
- Abnormally Decreased Muscle Contraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 8 Dec 2011 (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 purpose of this study was to evaluate feed-forward contraction of the transversus abdominis and thickness of the transversus abdominis, obliquus internus, and obliquus externus during calm and standardized respiration in low back pain patients and pain-free subjects.
Detailed description
Low back pain patients have alterations in abdominal wall function, especially in the feed-forward activation of transversus muscle during limbs movements. However, there are no reports on the abdominal function in low back pain patients during physiological respiratory movement.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nineteen women with low back pain | – | – |
| Twenty pain-free women | – | – |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (2 listed)
- For the low back pain group: women with history of non-specific chronic low back pain for more than three months
- For the pain-free group: pain-free women
Key exclusion criteria (3 listed)
- For both groups were: pregnancy, neurological condition, obesity (body mass index: BMI >30), or previous spine or abdominal surgery.
- For the low back pain group: rheumatology diseases other than low back pain.
- For the pain-free group: any rheumatology disease.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
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.
Clarice Tanaka, PhD principal investigator
Full Professor - Department of Physical Therapy, Communication Science & Disorders, Occupational Therapy, Faculty of Medicine - USP
Patricia R Patarro study chair
Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo, Brazil
Renato A Sernik study chair
Institute of Radiology, School of Medicine: University of São Paulo, Brazil
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 Abnormally Decreased Muscle Contraction, 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 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: finished, as of the sponsor's last update on 8 Dec 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 8 Dec 2011.