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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05336500
• Other study ID #: KAR/KAC
• Status: Completed
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: July 21, 2023

Study information

• Verified date: October 2022
• Source: Centro Universitário Augusto Motta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: July 21, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Pilates method exercises
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.

Locations

Country	Name	City	State
Brazil	Centro Universitário Augusto Motta	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitário Augusto Motta

Country where clinical trial is conducted

Brazil, 

References & Publications (22)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

Muscolino JE, Cipriani S. Pilates and the "powerhouse." Journal of Bodywork and Movement Therapies. 2016; 8: 15-24.

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	12 weeks post randomisation
Secondary	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).	12 weeks post randomisation