Low Back PainNCT03188003

Lumbo-pelvic Mobilization and Stabilization With Pilates Method in Low Back Pain and Movement Functionality

A study testing Exercise Movement Techniques based on mobilization and Exercise Movement Techniques based on stabilization in people with Low Back Pain and Pain, run by Federal University of Rio Grande do Sul at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 21 to 40 years
Conditions the study is for: Low Back Pain, Pain
What is being tested?: Exercise Movement Techniques based on mobilization and Exercise Movement Techniques based on stabilization
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteBrazil
Study dates: 1 Jun 2017to 20 Jan 2018
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 21 to 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Individuals of both sexes aged between 21 and 40 years;
Self-reported low back pain for at least 3 months;
Disability Oswestry Index greater than 10%.

Who cannot join

Diagnosis of pathognomonic low back pain caused by disc herniation with root involvement, inflammatory disorders, infections, osteoporosis, rheumatoid arthritis, fracture or tumor;
Medical contraindication to the practice of Pilates;
Childbirth or gestation in the last 6 months;
Be performing any type of treatment for low back pain is medicated, physiotherapeutic or alternative during the period of intervention;
Change the level of physical or sports activity during the intervention period;
Participants who miss two sessions in a row or four sessions alternately without retrieving them in the same week will automatically be excluded from the survey; Or do not attend pre and post-test evaluation events.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90690-200

Other trials in Brazil

About this study

Official title: Comparison of Lumbo-pelvic Mobilization and Stabilization Exercises With Pilates Method in Non-specific Chronic Low Back Pain and Movement Functionality

Lumbar pain is one of the most common injuries being the cause of morbidity in the individual generating occupational disability with strong personal, social and economic impact. As one of the methods of treatment, Pilates is a method that has good results for the management of this dysfunction. However, it is not known exactly which approach Pilates can bring better results for this population. Therefore, the purpose of this study is to compare the effects of two types of Pilates method interventions on non-specific chronic low back pain.

A blinded randomized clinical trial, will be held. 28 patients divided randomly into two groups will be assessed, the Mobilization Pilates (MP) and the Stabilization Pilates (SP). Both groups will be formed by individuals of both sexes and aged 21 to 41 years with chronic low back pain. Both groups will receive 10 sessions of Pilates Methods twice a week, with each session taking an average of 50 minutes, therefore the MP will focus on a lumbo-pelvic mobilization exercises approach and the SP will focus on lumbo-pelvic stabilization exercises approach. At the beginning and end of the 5 weeks the individuals are evaluated to verify the presence of pain and disability with VAS of pain and Oswestry Questionnaire, and also with the Functional Movement Screen. Data will be analyzed statistically.

Conditions: Low Back Pain, Pain
Being tested: Exercise Movement Techniques based on mobilization, Exercise Movement Techniques based on stabilization
Keywords: Exercise Movement Techniques, Low Back Pain, Exercise
Medical subject headings: Low Back Pain, Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exercise Movement Techniques based on mobilizationOther
10 sessions will be held twice a week, with each session taking an average of 50 minutes.
Exercise Movement Techniques based on stabilizationOther
10 sessions will be held twice a week, with each session taking an average of 50 minutes.

Study groups in NCT03188003
Study group	Role	What they receive
Stabilization	Experimental	This group will undergo 10 Pilates sessions with a focus on lumbo-pelvic stabilization exercises approach. Intervention administered: Exercise Movement Techniques (Pilates Exercise) based on stabilization Receives: Other: Exercise Movement Techniques based on stabilization
Mobilization	Experimental	This group will undergo 10 Pilates sessions with a focus on lumbo-pelvic mobilization exercises approach. Intervention administered: Exercise Movement Techniques (Pilates Exercise) based on mobilization Receives: Other: Exercise Movement Techniques based on mobilization

What is being measured

The primary outcome is the main question the study is designed to answer.

The change in Oswestry Low Back Disability Questionnaire
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools.
The oswestry questionarie will be evaluated in the first session and after 5 weeks of Pilates training. So, the primary outcome is the change in the Oswestry score from baseline to 5 weeks.
Measured: At the first session and 5 weeks after the intervention

Secondary outcomes (2)

The change in Visual Analog Scale for Pain (VAS)
Pain intensity will be assessed using visual analog scale (VAS), which consists of a 10-cm horizontal line in which "0" means "No pain" and "10" means "The worst pain I can imagine". This visual analog scale for pain will be evaluated in the first session and after 5 weeks of Pilates training. So, this outcome is the change in VAS score from baseline to 5 weeks.
Measured: At the first session and 5 weeks after the intervention
The change in The Functional Movement Screen (FMS)
The FMS is a screening for individuals who participate in physical activities by identifying limitations and restrictions in completing 7 movement tasks: deep squat, hurdle step, in-line lunch, shoulder mobility, active straight leg raise, trunk stability push-up, and rotatory stability.
Each one of these 7 movement tasks are scored on a 0-3 ordinal scale. The FMS output is a single result given by summing each movement's score. The maximum score is 21. The lower the score, the higher is the patient's risk for injury.
FMS will be evaluated before and after intervention. So, this outcome is the change in FMS score from baseline to 5 weeks.
Measured: At the first session and 5 weeks after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201720 Jan 2018

First posted15 Jun 2017
Study start1 Jun 2017
Primary completion30 Oct 2017
Study completion20 Jan 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03188003
Sponsor's protocol ID: MOB X STAB in Pilates
Status last verified: Dec 2017
First submitted: 18 May 2017
Last updated: 7 Dec 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Alves de Araujo ME, Bezerra da Silva E, Bragade Mello D, Cader SA, Shiguemi Inoue Salgado A, Dantas EH. The effectiveness of the Pilates method: reducing the degree of non-structural scoliosis, and improving flexibility and pain in female college students. J Bodyw Mov Ther. 2012 Apr;16(2):191-8. doi: 10.1016/j.jbmt.2011.04.002. Epub 2012 Jan 5.
PubMed 22464116
Cook G, Burton L, Hoogenboom B. Pre-participation screening: the use of fundamental movements as an assessment of function - part 1. N Am J Sports Phys Ther. 2006 May;1(2):62-72.
PubMed 21522216
Cook G, Burton L, Hoogenboom B. Pre-participation screening: the use of fundamental movements as an assessment of function - part 2. N Am J Sports Phys Ther. 2006 Aug;1(3):132-9.
PubMed 21522225
Cuchna JW, Hoch MC, Hoch JM. The interrater and intrarater reliability of the functional movement screen: A systematic review with meta-analysis. Phys Ther Sport. 2016 May;19:57-65. doi: 10.1016/j.ptsp.2015.12.002. Epub 2015 Dec 18.
PubMed 26777566
Miyamoto GC, Costa LO, Cabral CM. Efficacy of the Pilates method for pain and disability in patients with chronic nonspecific low back pain: a systematic review with meta-analysis. Braz J Phys Ther. 2013 Nov-Dec;17(6):517-32. doi: 10.1590/S1413-35552012005000127.
PubMed 24346291
Vigatto R, Alexandre NM, Correa Filho HR. Development of a Brazilian Portuguese version of the Oswestry Disability Index: cross-cultural adaptation, reliability, and validity. Spine (Phila Pa 1976). 2007 Feb 15;32(4):481-6. doi: 10.1097/01.brs.0000255075.11496.47.
PubMed 17304141

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Lumbo-pelvic Mobilization and Stabilization Exercises With Pilates Method in Non-specific Chronic Low Back Pain and Movement Functionality
ClinicalTrials.gov ID: NCT03188003
Acronym / sponsor ID: MOB X STAB in Pilates
Conditions: Low Back Pain, Pain
Keywords: Exercise Movement Techniques, Low Back Pain, Exercise
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 28 participants (actual)
Lead sponsor: Federal University of Rio Grande do SulUniversity, hospital or other
Study start: 1 Jun 2017 (actual)
Primary completion: 30 Oct 2017 (actual)
Study completion: 20 Jan 2018 (estimated)
First posted: 15 Jun 2017 (actual)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Stabilization	Experimental	Other: Exercise Movement Techniques based on stabilizationThis group will undergo 10 Pilates sessions with a focus on lumbo-pelvic stabilization exercises approach. Intervention administered: Exercise Movement Techniques (Pilates Exercise) based on stabilization
Mobilization	Experimental	Other: Exercise Movement Techniques based on mobilizationThis group will undergo 10 Pilates sessions with a focus on lumbo-pelvic mobilization exercises approach. Intervention administered: Exercise Movement Techniques (Pilates Exercise) based on mobilization

Who may qualify

Ages: 21 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Individuals of both sexes aged between 21 and 40 years;
Self-reported low back pain for at least 3 months;
Disability Oswestry Index greater than 10%.

Key exclusion criteria (6 listed)

Diagnosis of pathognomonic low back pain caused by disc herniation with root involvement, inflammatory disorders, infections, osteoporosis, rheumatoid arthritis, fracture or tumor;
Medical contraindication to the practice of Pilates;
Childbirth or gestation in the last 6 months;
Be performing any type of treatment for low back pain is medicated, physiotherapeutic or alternative during the period of intervention;
Change the level of physical or sports activity during the intervention period;

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
Exercise Movement Techniques based on mobilization10 sessions will be held twice a week, with each session taking an average of 50 minutes.	Other	Mobilization
Exercise Movement Techniques based on stabilization10 sessions will be held twice a week, with each session taking an average of 50 minutes.	Other	Stabilization

Primary outcome

The change in Oswestry Low Back Disability Questionnaire
Time frame: At the first session and 5 weeks after the intervention
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. The oswestry questionarie will be evaluated in the first session and after 5 weeks of Pilates training. So, the primary outcome is the change in the Oswestry score from baseline to 5 weeks.

2 secondary outcomes

The change in Visual Analog Scale for Pain (VAS)
Time frame: At the first session and 5 weeks after the intervention
The change in The Functional Movement Screen (FMS)
Time frame: At the first session and 5 weeks after the intervention

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
Background: PubMed 22464116Alves de Araujo ME, Bezerra da Silva E, Bragade Mello D, Cader SA, Shiguemi Inoue Salgado A, Dantas EH. The effectiveness of the Pilates method: reducing the degree of non-structural scoliosis, and improving flexibility and pain in female college students. J Bodyw Mov Ther. 2012 Apr;16(2):191-8. doi: 10.1016/j.jbmt.2011.04.002. Epub 2012 Jan 5.
Background: PubMed 21522216Cook G, Burton L, Hoogenboom B. Pre-participation screening: the use of fundamental movements as an assessment of function - part 1. N Am J Sports Phys Ther. 2006 May;1(2):62-72.
Background: PubMed 21522225Cook G, Burton L, Hoogenboom B. Pre-participation screening: the use of fundamental movements as an assessment of function - part 2. N Am J Sports Phys Ther. 2006 Aug;1(3):132-9.
Background: PubMed 26777566Cuchna JW, Hoch MC, Hoch JM. The interrater and intrarater reliability of the functional movement screen: A systematic review with meta-analysis. Phys Ther Sport. 2016 May;19:57-65. doi: 10.1016/j.ptsp.2015.12.002. Epub 2015 Dec 18.
Background: PubMed 24346291Miyamoto GC, Costa LO, Cabral CM. Efficacy of the Pilates method for pain and disability in patients with chronic nonspecific low back pain: a systematic review with meta-analysis. Braz J Phys Ther. 2013 Nov-Dec;17(6):517-32. doi: 10.1590/S1413-35552012005000127.
Background: PubMed 17304141Vigatto R, Alexandre NM, Correa Filho HR. Development of a Brazilian Portuguese version of the Oswestry Disability Index: cross-cultural adaptation, reliability, and validity. Spine (Phila Pa 1976). 2007 Feb 15;32(4):481-6. doi: 10.1097/01.brs.0000255075.11496.47.
Individual participant dataSharing planned: No

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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.

Jefferson F Loss, PhD study director

Federal University of Rio Grande do Sul

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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 7 Dec 2017. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in Oswestry Low Back Disability Questionnaire (time frame: At the first session and 5 weeks after the intervention). 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 NCT03188003, which also lists 6 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 7 Dec 2017.