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

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ClinicalTrials.gov Identifier: NCT03188003
Recruitment Status : Unknown
Verified December 2017 by Jefferson Fagundes Loss, Federal University of Rio Grande do Sul.
Recruitment status was:  Active, not recruiting
First Posted : June 15, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Jefferson Fagundes Loss, Federal University of Rio Grande do Sul

Brief 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.


Condition or disease Intervention/treatment Phase
Low Back Pain Pain Other: Exercise Movement Techniques based on mobilization Other: Exercise Movement Techniques based on stabilization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Lumbo-pelvic Mobilization and Stabilization Exercises With Pilates Method in Non-specific Chronic Low Back Pain and Movement Functionality
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : October 30, 2017
Estimated Study Completion Date : January 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stabilization

This group will undergo 10 Pilates sessions with a focus on lumbo-pelvic stabilization exercises approach.

Intervention administered: Exercise Movement Techniques (Pilates Exercise) based on stabilization

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

Experimental: Mobilization

This group will undergo 10 Pilates sessions with a focus on lumbo-pelvic mobilization exercises approach.

Intervention administered: Exercise Movement Techniques (Pilates Exercise) based on mobilization

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




Primary Outcome Measures :
  1. The change in Oswestry Low Back Disability Questionnaire [ Time Frame: At the first session and 5 weeks after the intervention ]

    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.



Secondary Outcome Measures :
  1. The change in Visual Analog Scale for Pain (VAS) [ Time Frame: At the first session and 5 weeks after the intervention ]
    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.

  2. The change in The Functional Movement Screen (FMS) [ Time Frame: At the first session and 5 weeks after the intervention ]

    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.




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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188003


Locations
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Brazil
Universidade Federal do Rio Grande do Sul
Porto Alegre, RS, Brazil, 90690-200
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Investigators
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Study Director: Jefferson F Loss, PhD Federal University of Rio Grande do Sul
Publications:
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Responsible Party: Jefferson Fagundes Loss, Doctor, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT03188003    
Other Study ID Numbers: MOB X STAB in Pilates
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jefferson Fagundes Loss, Federal University of Rio Grande do Sul:
Exercise Movement Techniques
Low Back Pain
Exercise
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations