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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03188003
• Other study ID #: MOB X STAB in Pilates
• Status: Active, not recruiting
• Phase: N/A
• First received: May 18, 2017
• Last updated: December 5, 2017
• Start date: June 1, 2017
• Est. completion date: January 20, 2018

Study information

• Verified date: December 2017
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: January 20, 2018
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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%.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Pain

Intervention

Other:
• Exercise Movement Techniques based on mobilization
10 sessions will be held twice a week, with each session taking an average of 50 minutes.
• Exercise Movement Techniques based on stabilization
10 sessions will be held twice a week, with each session taking an average of 50 minutes.

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio Grande do Sul	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

Alves de Araújo 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. English, Portuguese. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the first session and 5 weeks after the intervention
Secondary	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.	At the first session and 5 weeks after the intervention
Secondary	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.	At the first session and 5 weeks after the intervention