Low Back PainNCT05336500

Effectiveness of Education to Keep the Abdomen Relaxed Versus Contracted During Pilates

A study testing Pilates method exercises in people with Low Back Pain, run by Centro Universitário Augusto Motta at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to investigate the effectiveness of education to keep the abdomen relaxed versus contracted during Pilates exercises in patients with primary chronic low back pain. Participants will be randomised into two groups that will be treated with Pilates exercises for 12 weeks. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Back Pain
What is being tested?: Pilates method exercises
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 152 participants
Where: 1 siteBrazil
Study dates: 6 Jun 2022to 21 Jul 2023
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged from 18 years old;
Low back pain for more than 3 months;
Disability level ≥ 4 points on the Roland-Morris Disability Questionnaire (RMDQ);
Ability to move independently with or without assistance;
Ability to understand Portuguese enough to be able to fill in the questionnaires.

Who cannot join

The main area of pain other than the lumbar spine (eg, nerve root compression or herniated disc with radicular pain, lateral or central stenosis);
Surgery performed on the lumbar spine.
Surgery performed on the lower limbs, or abdominal region less than 6 months ago;
Performing an invasive procedure for pain relief (eg, epidural injection, rhizotomy) in the last 3 months;
Diagnosis of inflammatory rheumatologic diseases, progressive neurological disease, or viral diseases as the primary cause of pain;
Scoliosis as the primary cause of pain;
Unstable heart conditions;
Presence of red flags such as malignancy/cancer, acute trauma (less than 6 months), infection, spinal cord/cauda equina compression.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Centro Universitário Augusto Motta
Rio de Janeiro, 21.041-020

Other trials in Brazil

About this study

Official title: Effectiveness of Education to Keep the Abdomen Relaxed Versus Contracted During Pilates Exercises in Patients With Primary Chronic Low Back Pain: a Randomised Controlled Trial

This study aims to investigate the effectiveness of education to keep the abdomen relaxed versus contracted during Pilates exercises in patients with primary chronic low back pain.

Participants will be randomised into two groups that will be treated with Pilates exercises for 12 weeks. The control group will receive guidance on the specific activation of the center of strength (the powerhouse), while the experimental group will receive guidance to perform the exercises in a relaxed and smooth way. Primary outcomes will be pain intensity and disability 12 weeks post randomisation.

Conditions: Low Back Pain
Being tested: Pilates method exercises
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 method exercisesOther
Participants will be randomised into two groups that will be treated with Pilates exercises for 12 weeks (twice a week for 60 minutes). The control group will receive guidance on the specific activation of the center of strength (the powerhouse), while the experimental group will receive guidance to perform the exercises in a relaxed and smooth way.

Study groups in NCT05336500
Study group	Role	What they receive
Pilates method exercises associated with education to keep the abdomen relaxed	Experimental	The group will receive guidance to perform the exercises in a relaxed and smooth way Receives: Other: Pilates method exercises
Pilates method exercises associated with education to keep the abdomen contracted	Active comparator	The group will receive guidance on the specific activation of the center of strength (the powerhouse) Receives: Other: Pilates method exercises

What is being measured

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

Pain intensity
Pain intensity will be obtained through self-report by the Brazilian version of the 11-point Numerical Pain Scale (NPS) (Costa et al., 2008; Vigotsky et al., 2021), which varies between 0 and 10 points, where 0 is "no pain" and 10 is "the worst pain imaginable" where individuals should report pain intensity based on the last 7 days.
Measured: 12 weeks post randomisation
Disability related
Disability will be obtained through self-report by the Brazilian version of the Roland-Morris Disability Questionnaire (RMDQ) (Nusbaum et al., 2001), which has 24 statements involving activities and pain situations, to which the patient is instructed to answer "yes" only to those described in the assessment day, and each answer corresponds to one point.
Measured: 12 weeks post randomisation

Secondary outcomes (2)

Perception of global improvement
Perception of global improvement will be obtained through self-report by the Perception of Global Effect Scale (PGES), 11 points ranging from -5 ("much worse"), 0 ("no change") to +5 (completely recovered) (Costa et al., 2008). For all measures of perceived global effect participants will be asked: "Compared to the start of your first episode, how do you describe your low back pain in the past few days?". A highly positive score indicates greater recovery, while a negative score indicates worsening of symptoms.
Measured: 12 weeks post randomisation
Specific functionality
Specific functionality will be obtained through self-report by the Patient-specific functional scale (PSFS) (Costa et al., 2008), which consists of an interview in which the patient chooses three important activities whose execution is difficult or impossible due to low back pain. For each activity, a score of difficulty ranges from 0 (unable to perform) to 10 (able to perform at the same level as before the problem).
Measured: 12 weeks post randomisation

Timeline

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

6 Jun 202221 Jul 2023

First posted20 Apr 2022
Study start6 Jun 2022
Primary completion20 Apr 2023
Study completion21 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)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: Single blind
Who is masked: Outcomes assessor
Enrolment: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05336500
Sponsor's protocol ID: KAR/KAC
Status last verified: Oct 2022
First submitted: 12 Apr 2022
Last updated: 8 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Costa LO, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, Freitas LM. Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best? Spine (Phila Pa 1976). 2008 Oct 15;33(22):2459-63. doi: 10.1097/BRS.0b013e3181849dbe.
PubMed 18923324
Nusbaum L, Natour J, Ferraz MB, Goldenberg J. Translation, adaptation and validation of the Roland-Morris questionnaire--Brazil Roland-Morris. Braz J Med Biol Res. 2001 Feb;34(2):203-10. doi: 10.1590/s0100-879x2001000200007.
PubMed 11175495
Vigotsky AD, Tiwari SR, Griffith JW, Apkarian AV. What Is the Numerical Nature of Pain Relief? Front Pain Res (Lausanne). 2021 Nov 2;2:756680. doi: 10.3389/fpain.2021.756680. eCollection 2021.
PubMed 35295426
Campbell A, Kemp-Smith K, O'Sullivan P, Straker L. Abdominal Bracing Increases Ground Reaction Forces and Reduces Knee and Hip Flexion During Landing. J Orthop Sports Phys Ther. 2016 Apr;46(4):286-92. doi: 10.2519/jospt.2016.5774. Epub 2016 Mar 8.
PubMed 26954271
Coenen P, Campbell A, Kemp-Smith K, O'Sullivan P, Straker L. Abdominal bracing during lifting alters trunk muscle activity and body kinematics. Appl Ergon. 2017 Sep;63:91-98. doi: 10.1016/j.apergo.2017.04.009. Epub 2017 Apr 22.
PubMed 28502411
Eliks M, Zgorzalewicz-Stachowiak M, Zenczak-Praga K. Application of Pilates-based exercises in the treatment of chronic non-specific low back pain: state of the art. Postgrad Med J. 2019 Jan;95(1119):41-45. doi: 10.1136/postgradmedj-2018-135920. Epub 2019 Jan 12.
PubMed 30636192
Foster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP, Ferreira PH, Fritz JM, Koes BW, Peul W, Turner JA, Maher CG; Lancet Low Back Pain Series Working Group. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet. 2018 Jun 9;391(10137):2368-2383. doi: 10.1016/S0140-6736(18)30489-6. Epub 2018 Mar 21.
PubMed 29573872
Fuhro FF, Fagundes FRC, Manzoni ACT, Costa LOP, Cabral CMN. Orebro Musculoskeletal Pain Screening Questionnaire Short-Form and STarT Back Screening Tool: Correlation and Agreement Analysis. Spine (Phila Pa 1976). 2016 Aug 1;41(15):E931-E936. doi: 10.1097/BRS.0000000000001415.
PubMed 26720177
Gubler D, Mannion AF, Schenk P, Gorelick M, Helbling D, Gerber H, Toma V, Sprott H. Ultrasound tissue Doppler imaging reveals no delay in abdominal muscle feed-forward activity during rapid arm movements in patients with chronic low back pain. Spine (Phila Pa 1976). 2010 Jul 15;35(16):1506-13. doi: 10.1097/BRS.0b013e3181c3ed41.
PubMed 20431436
Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
PubMed 29573870
Hayden JA, Ellis J, Ogilvie R, Malmivaara A, van Tulder MW. Exercise therapy for chronic low back pain. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD009790. doi: 10.1002/14651858.CD009790.pub2.
PubMed 34580864
Hoffman J, Gabel CP. The origins of Western mind-body exercise methods. Phys Ther Rev. 2015 Nov 2;20(5-6):315-324. doi: 10.1080/10833196.2015.1125587. Epub 2016 Apr 8.
PubMed 27695277
Latey P. The Pilates method: history and philosophy. Journal of Bodywork and Movement Therapies. , 2001; 5: 275-282.
Lima M, Ferreira AS, Reis FJJ, Paes V, Meziat-Filho N. Chronic low back pain and back muscle activity during functional tasks. Gait Posture. 2018 Mar;61:250-256. doi: 10.1016/j.gaitpost.2018.01.021. Epub 2018 Mar 20.
PubMed 29413793
Maced, CSG, Debiagi PC, Andrade FM. The Isostretching effect in the muscle strength of gluteus maximus, abdominal and the trunk extensor, incapacity and pain in patients with low back pain. Fisioter. Mov. 2010; 23: 113-120.

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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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Education to Keep the Abdomen Relaxed Versus Contracted During Pilates Exercises in Patients With Primary Chronic Low Back Pain: a Randomised Controlled Trial
ClinicalTrials.gov ID: NCT05336500
Acronym / sponsor ID: KAR/KAC
Conditions: Low Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 152 participants (actual)
Lead sponsor: Centro Universitário Augusto MottaUniversity, hospital or other
Study start: 6 Jun 2022 (actual)
Primary completion: 20 Apr 2023 (actual)
Study completion: 21 Jul 2023 (actual)
First posted: 20 Apr 2022 (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.

This study aims to investigate the effectiveness of education to keep the abdomen relaxed versus contracted during Pilates exercises in patients with primary chronic low back pain.

Study design

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

Arm	Type	Receives
Pilates method exercises associated with education to keep the abdomen relaxed	Experimental	Other: Pilates method exercisesThe group will receive guidance to perform the exercises in a relaxed and smooth way
Pilates method exercises associated with education to keep the abdomen contracted	Active comparator	Other: Pilates method exercisesThe group will receive guidance on the specific activation of the center of strength (the powerhouse)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Aged from 18 years old;
Low back pain for more than 3 months;
Disability level ≥ 4 points on the Roland-Morris Disability Questionnaire (RMDQ);
Ability to move independently with or without assistance;
Ability to understand Portuguese enough to be able to fill in the questionnaires.

Key exclusion criteria (8 listed)

The main area of pain other than the lumbar spine (eg, nerve root compression or herniated disc with radicular pain, lateral or central stenosis);
Surgery performed on the lumbar spine.
Surgery performed on the lower limbs, or abdominal region less than 6 months ago;
Performing an invasive procedure for pain relief (eg, epidural injection, rhizotomy) in the last 3 months;
Diagnosis of inflammatory rheumatologic diseases, progressive neurological disease, or viral diseases as the primary cause of 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
Pilates method exercisesParticipants will be randomised into two groups that will be treated with Pilates exercises for 12 weeks (twice a week for 60 minutes). The control group will receive guidance on the specific activation of the center of strength (the powerhouse), while the experimental group will receive guidance to perform the exercises in a relaxed and smooth way.	Other	Pilates method exercises associated with education to keep the abdomen contracted, Pilates method exercises associated with education to keep the abdomen relaxed

Primary outcome

Pain intensity
Time frame: 12 weeks post randomisation
Pain intensity will be obtained through self-report by the Brazilian version of the 11-point Numerical Pain Scale (NPS) (Costa et al., 2008; Vigotsky et al., 2021), which varies between 0 and 10 points, where 0 is "no pain" and 10 is "the worst pain imaginable" where individuals should report pain intensity based on the last 7 days.
Disability related
Time frame: 12 weeks post randomisation
Disability will be obtained through self-report by the Brazilian version of the Roland-Morris Disability Questionnaire (RMDQ) (Nusbaum et al., 2001), which has 24 statements involving activities and pain situations, to which the patient is instructed to answer "yes" only to those described in the assessment day, and each answer corresponds to one point.

2 secondary outcomes

Perception of global improvement
Time frame: 12 weeks post randomisation
Specific functionality
Time frame: 12 weeks post randomisation

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 Aug 2023.
Background: PubMed 18923324Costa LO, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, Freitas LM. Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best? Spine (Phila Pa 1976). 2008 Oct 15;33(22):2459-63. doi: 10.1097/BRS.0b013e3181849dbe.
Background: PubMed 11175495Nusbaum L, Natour J, Ferraz MB, Goldenberg J. Translation, adaptation and validation of the Roland-Morris questionnaire--Brazil Roland-Morris. Braz J Med Biol Res. 2001 Feb;34(2):203-10. doi: 10.1590/s0100-879x2001000200007.
Background: PubMed 35295426Vigotsky AD, Tiwari SR, Griffith JW, Apkarian AV. What Is the Numerical Nature of Pain Relief? Front Pain Res (Lausanne). 2021 Nov 2;2:756680. doi: 10.3389/fpain.2021.756680. eCollection 2021.
Background: PubMed 26954271Campbell A, Kemp-Smith K, O'Sullivan P, Straker L. Abdominal Bracing Increases Ground Reaction Forces and Reduces Knee and Hip Flexion During Landing. J Orthop Sports Phys Ther. 2016 Apr;46(4):286-92. doi: 10.2519/jospt.2016.5774. Epub 2016 Mar 8.
Background: PubMed 28502411Coenen P, Campbell A, Kemp-Smith K, O'Sullivan P, Straker L. Abdominal bracing during lifting alters trunk muscle activity and body kinematics. Appl Ergon. 2017 Sep;63:91-98. doi: 10.1016/j.apergo.2017.04.009. Epub 2017 Apr 22.
Background: PubMed 30636192Eliks M, Zgorzalewicz-Stachowiak M, Zenczak-Praga K. Application of Pilates-based exercises in the treatment of chronic non-specific low back pain: state of the art. Postgrad Med J. 2019 Jan;95(1119):41-45. doi: 10.1136/postgradmedj-2018-135920. Epub 2019 Jan 12.
Background: PubMed 29573872Foster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP, Ferreira PH, Fritz JM, Koes BW, Peul W, Turner JA, Maher CG; Lancet Low Back Pain Series Working Group. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet. 2018 Jun 9;391(10137):2368-2383. doi: 10.1016/S0140-6736(18)30489-6. Epub 2018 Mar 21.
Background: PubMed 26720177Fuhro FF, Fagundes FRC, Manzoni ACT, Costa LOP, Cabral CMN. Orebro Musculoskeletal Pain Screening Questionnaire Short-Form and STarT Back Screening Tool: Correlation and Agreement Analysis. Spine (Phila Pa 1976). 2016 Aug 1;41(15):E931-E936. doi: 10.1097/BRS.0000000000001415.
Background: PubMed 20431436Gubler D, Mannion AF, Schenk P, Gorelick M, Helbling D, Gerber H, Toma V, Sprott H. Ultrasound tissue Doppler imaging reveals no delay in abdominal muscle feed-forward activity during rapid arm movements in patients with chronic low back pain. Spine (Phila Pa 1976). 2010 Jul 15;35(16):1506-13. doi: 10.1097/BRS.0b013e3181c3ed41.
Background: PubMed 29573870Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
Background: PubMed 34580864Hayden JA, Ellis J, Ogilvie R, Malmivaara A, van Tulder MW. Exercise therapy for chronic low back pain. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD009790. doi: 10.1002/14651858.CD009790.pub2.
Background: PubMed 27695277Hoffman J, Gabel CP. The origins of Western mind-body exercise methods. Phys Ther Rev. 2015 Nov 2;20(5-6):315-324. doi: 10.1080/10833196.2015.1125587. Epub 2016 Apr 8.
Individual participant dataSharing planned: No

Related trials for Low Back Pain

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Not yet recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 method exercises in people with Low Back Pain, run by Centro Universitário Augusto Motta 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 8 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 Aug 2023. 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.

What does the primary outcome measure?

Pain intensity (time frame: 12 weeks post randomisation). The study lists 2 primary outcomes in all. 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 NCT05336500, which also lists 24 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 8 Aug 2023.