NCT05336500

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 6, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2023

Completed
Last Updated

August 8, 2023

Status Verified

October 1, 2022

Enrollment Period

11 months

First QC Date

April 12, 2022

Last Update Submit

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

EXPERIMENTAL

The group will receive guidance to perform the exercises in a relaxed and smooth way

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)

Other: Pilates method exercises

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.

Pilates method exercises associated with education to keep the abdomen contractedPilates method exercises associated with education to keep the abdomen relaxed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 18923324BACKGROUND
  • 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.

    PMID: 11175495BACKGROUND
  • 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.

    PMID: 35295426BACKGROUND
  • 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.

    PMID: 26954271BACKGROUND
  • 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.

    PMID: 28502411BACKGROUND
  • 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.

    PMID: 30636192BACKGROUND
  • 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.

    PMID: 29573872BACKGROUND
  • 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.

    PMID: 26720177BACKGROUND
  • 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.

    PMID: 20431436BACKGROUND
  • 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.

    PMID: 29573870BACKGROUND
  • 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.

    PMID: 34580864BACKGROUND
  • 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.

    PMID: 27695277BACKGROUND
  • Latey P. The Pilates method: history and philosophy. Journal of Bodywork and Movement Therapies. , 2001; 5: 275-282.

    BACKGROUND
  • 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.

    PMID: 29413793BACKGROUND
  • 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.

    BACKGROUND
  • Maher 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: 27745712BACKGROUND
  • Mostagi 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: 26592221BACKGROUND
  • Muscolino JE, Cipriani S. Pilates and the "powerhouse." Journal of Bodywork and Movement Therapies. 2016; 8: 15-24.

    BACKGROUND
  • Silva 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.

    BACKGROUND
  • Sterne 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: 19564179BACKGROUND
  • Wajswelner 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: 22246216BACKGROUND
  • Wells 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: 22579438BACKGROUND
  • Lunkes 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.

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations