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

Primary Purpose

Low Back Pain, Pain

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise Movement Techniques based on mobilization
Exercise Movement Techniques based on stabilization
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Exercise Movement Techniques, Low Back Pain, Exercise

Eligibility Criteria

21 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal do Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stabilization

Mobilization

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 18, 2017
Last Updated
December 5, 2017
Sponsor
Federal University of Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT03188003
Brief Title
Lumbo-pelvic Mobilization and Stabilization With Pilates Method in Low Back Pain and Movement Functionality
Official Title
Comparison of Lumbo-pelvic Mobilization and Stabilization Exercises With Pilates Method in Non-specific Chronic Low Back Pain and Movement Functionality
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
January 20, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Pain
Keywords
Exercise Movement Techniques, Low Back Pain, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stabilization
Arm Type
Experimental
Arm Description
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
Arm Title
Mobilization
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Exercise Movement Techniques based on mobilization
Intervention Description
10 sessions will be held twice a week, with each session taking an average of 50 minutes.
Intervention Type
Other
Intervention Name(s)
Exercise Movement Techniques based on stabilization
Intervention Description
10 sessions will be held twice a week, with each session taking an average of 50 minutes.
Primary Outcome Measure Information:
Title
The change in Oswestry Low Back Disability Questionnaire
Description
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.
Time Frame
At the first session and 5 weeks after the intervention
Secondary Outcome Measure Information:
Title
The change in Visual Analog Scale for Pain (VAS)
Description
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.
Time Frame
At the first session and 5 weeks after the intervention
Title
The change in The Functional Movement Screen (FMS)
Description
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.
Time Frame
At the first session and 5 weeks after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jefferson F Loss, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Sul
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90690-200
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22464116
Citation
Alves de Araujo 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.
Results Reference
background
PubMed Identifier
21522216
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.
Results Reference
background
PubMed Identifier
21522225
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.
Results Reference
background
PubMed Identifier
26777566
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.
Results Reference
background
PubMed Identifier
24346291
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.
Results Reference
background
PubMed Identifier
17304141
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. doi: 10.1097/01.brs.0000255075.11496.47.
Results Reference
background

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

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