Effectiveness of Education to Keep the Abdomen Relaxed Versus Contracted During Pilates
1 other identifier
interventional
152
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Jun 2022
Typical duration for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2022
CompletedFirst Posted
Study publicly available on registry
April 20, 2022
CompletedStudy Start
First participant enrolled
June 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2023
CompletedAugust 8, 2023
October 1, 2022
11 months
April 12, 2022
August 4, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
12 weeks post randomisation
Secondary Outcomes (2)
Perception of global improvement
12 weeks post randomisation
Specific functionality
12 weeks post randomisation
Study Arms (2)
Pilates method exercises associated with education to keep the abdomen relaxed
EXPERIMENTALThe 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 COMPARATORThe group will receive guidance on the specific activation of the center of strength (the powerhouse)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Universitário Augusto Motta
Rio de Janeiro, 21.041-020, Brazil
Related Publications (23)
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.
PMID: 18923324BACKGROUNDNusbaum 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.
PMID: 11175495BACKGROUNDVigotsky 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.
PMID: 35295426BACKGROUNDCampbell 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.
PMID: 26954271BACKGROUNDCoenen 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.
PMID: 28502411BACKGROUNDEliks 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.
PMID: 30636192BACKGROUNDFoster 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.
PMID: 29573872BACKGROUNDFuhro 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.
PMID: 26720177BACKGROUNDGubler 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.
PMID: 20431436BACKGROUNDHartvigsen 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.
PMID: 29573870BACKGROUNDHayden 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.
PMID: 34580864BACKGROUNDHoffman 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.
PMID: 27695277BACKGROUNDLatey P. The Pilates method: history and philosophy. Journal of Bodywork and Movement Therapies. , 2001; 5: 275-282.
BACKGROUNDLima 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.
PMID: 29413793BACKGROUNDMaced, 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.
BACKGROUNDMaher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
PMID: 27745712BACKGROUNDMostagi FQ, Dias JM, Pereira LM, Obara K, Mazuquin BF, Silva MF, Silva MA, de Campos RR, Barreto MS, Nogueira JF, Lima TB, Carregaro RL, Cardoso JR. Pilates versus general exercise effectiveness on pain and functionality in non-specific chronic low back pain subjects. J Bodyw Mov Ther. 2015 Oct;19(4):636-45. doi: 10.1016/j.jbmt.2014.11.009. Epub 2014 Nov 18.
PMID: 26592221BACKGROUNDMuscolino JE, Cipriani S. Pilates and the "powerhouse." Journal of Bodywork and Movement Therapies. 2016; 8: 15-24.
BACKGROUNDSilva PHB, Silva DF, Oliveira JKS, Oliveira FB. The effect of the Pilates method on the treatment of chronic low back pain: a clinical, randomized, controlled study. Brazilian Journal Of Pain. 2018; 1: 21-28.
BACKGROUNDSterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, Wood AM, Carpenter JR. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009 Jun 29;338:b2393. doi: 10.1136/bmj.b2393.
PMID: 19564179BACKGROUNDWajswelner H, Metcalf B, Bennell K. Clinical pilates versus general exercise for chronic low back pain: randomized trial. Med Sci Sports Exerc. 2012 Jul;44(7):1197-205. doi: 10.1249/MSS.0b013e318248f665.
PMID: 22246216BACKGROUNDWells C, Kolt GS, Bialocerkowski A. Defining Pilates exercise: a systematic review. Complement Ther Med. 2012 Aug;20(4):253-62. doi: 10.1016/j.ctim.2012.02.005. Epub 2012 Mar 13.
PMID: 22579438BACKGROUNDLunkes LC, Dias Neto MA, Barra LF, de Castro LR, Ferreira AS, Meziat-Filho N. Education to keep the abdomen relaxed versus contracted during pilates in patients with chronic low back pain: study protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2023 Jan 20;24(1):49. doi: 10.1186/s12891-023-06160-z.
PMID: 36670384DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2022
First Posted
April 20, 2022
Study Start
June 6, 2022
Primary Completion
April 20, 2023
Study Completion
July 21, 2023
Last Updated
August 8, 2023
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share