Low Back PainNCT01533805
Effects of Different Techniques of the Method Pilates in Chronic Low Back Pain
A study testing Pilates exercises with stabilization and Classic Pilates in people with Low Back Pain, run by Universidade Gama Filho at 1 site in Brazil.
Trial summary
The purpose of this study is to compare different methods of application of the Pilates Method with exercises in controlling in low back pain in women aged between 45 and 60 years. Two groups will be formed. One will do Pilates exercises with stabilization segmental. The other group will do classic Pilates exercises. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Pilates exercises with stabilization and Classic Pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2012to Dec 2012
- 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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Chronic low back pain classified by visual analogue scale being 3-6 points to more than 3 weeks
- Not be performing any other type of physical therapy
Who cannot join
- Pregnant women
- Back surgeries
- Cardiovascular and rheumatic diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Gama Filho University
Rio de Janeiro, Rio de Janeiro, 23050-260
Cintia P Souza, bachelor, 2181320046, centropilates@bol.com.br
About this study
Official title: Effects of Different Techniques of the Method Pilates in Chronic Low Back Pain in Women 46 to 60 Years
The purpose of this study is to compare different methods of application of the Pilates Method with exercises in controlling in low back pain in women aged between 45 and 60 years. Two groups will be formed. One will do Pilates exercises with stabilization segmental. The other group will do classic Pilates exercises. Will be measure pre and pos intervention of the responses already shown above.
Read the detailed description
The purpose of this study is to identify what type of Pilates exercise is more effective in controlling low back pain is exercise that uses the method of the classical manner or trunk mobilizations with exercises that target the neutral position of the lumbar spine and deep muscles and focus on stabilizing the trunk.
- Conditions
- Low Back Pain
- Being tested
- Pilates exercises with stabilization, Classic Pilates
- Keywords
- Lumbago, Exercise therapy, Spine
- 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.
Pilates exercises with stabilizationOther
Also called Pilates with stabilization segmental
This group will focus on exercises with core stabilizing muscles. The frequency will be 16 sessions lasting 1 hour.
Classic PilatesOther
This group will make Pilates exercises its focus is on mobilization exercises of the lumbar spine. The frequency will be 16 sessions lasting 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Pilates with stabilization | Experimental | This group will do pilates exercises with a focus on control of segmental stabilization of the lumbar spine neutral. Receives: Other: Pilates exercises with stabilization |
| Classic Pilates | Active comparator | This group will make Pilates exercises its focus is on mobilization exercises of the lumbar spine. Receives: Other: Classic Pilates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
low back pain will be assessed with numeric pain scale two times (pre and post-intervention)
Measured: Up to 8 weeks
Secondary outcomes (3)
Endurance of the back extensor muscles
The endurance of the back extensor muscles will be assessed Biering-Sorensen test
Measured: Up to 8 weeks
Activity of abdominis transversus
Will be assessed with Biofeedback pressure stabilizer
Measured: Up to 8 weeks
Functional Limitation
Will be assessed Rolland Morris Test
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Gama Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cintia Pereira de Souza, Universidade Gama Filho
- Investigators
- Cintia P Souza, bachelor, Principal investigator, University Gama Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533805
- Sponsor's protocol ID
- CAAE 0119031200011
- Status last verified
- Feb 2012
- First submitted
- 2 Feb 2012
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Techniques of the Method Pilates in Chronic Low Back Pain in Women 46 to 60 Years
- ClinicalTrials.gov ID
- NCT01533805
- Acronym / sponsor ID
- CAAE 0119031200011
- Conditions
- Low Back Pain
- Keywords
- Lumbago, Exercise therapy, Spine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade Gama FilhoUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 15 Feb 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 purpose of this study is to compare different methods of application of the Pilates Method with exercises in controlling in low back pain in women aged between 45 and 60 years. Two groups will be formed. One will do Pilates exercises with stabilization segmental. The other group will do classic Pilates exercises. Will be measure pre and pos intervention of the responses already shown above.
Detailed description
The purpose of this study is to identify what type of Pilates exercise is more effective in controlling low back pain is exercise that uses the method of the classical manner or trunk mobilizations with exercises that target the neutral position of the lumbar spine and deep muscles and focus on stabilizing the trunk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates with stabilization | Experimental | Other: Pilates exercises with stabilizationThis group will do pilates exercises with a focus on control of segmental stabilization of the lumbar spine neutral. |
| Classic Pilates | Active comparator | Other: Classic PilatesThis group will make Pilates exercises its focus is on mobilization exercises of the lumbar spine. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Chronic low back pain classified by visual analogue scale being 3-6 points to more than 3 weeks
- Not be performing any other type of physical therapy
Key exclusion criteria (3 listed)
- Pregnant women
- Back surgeries
- Cardiovascular and rheumatic diseases
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 |
|---|---|---|
| Pilates exercises with stabilizationAlso: Pilates with stabilization segmentalThis group will focus on exercises with core stabilizing muscles. The frequency will be 16 sessions lasting 1 hour. | Other | Pilates with stabilization |
| Classic PilatesThis group will make Pilates exercises its focus is on mobilization exercises of the lumbar spine. The frequency will be 16 sessions lasting 1 hour. | Other | Classic Pilates |
Primary outcome
Pain
Time frame: Up to 8 weeks
low back pain will be assessed with numeric pain scale two times (pre and post-intervention)
3 secondary outcomes
Endurance of the back extensor muscles
Time frame: Up to 8 weeks
Activity of abdominis transversus
Time frame: Up to 8 weeks
Functional Limitation
Time frame: Up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
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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.
Cintia P Souza, bachelor principal investigator
University Gama Filho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercises with stabilization and Classic Pilates in people with Low Back Pain, run by Universidade Gama Filho 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: status not confirmed, as of the sponsor's last update on 15 Feb 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 Cintia P Souza, Bachelor (552181320046, centropilates@bol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Up to 8 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 15 Feb 2012.