NCT03188003

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

May 18, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2018

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

May 18, 2017

Last Update Submit

December 5, 2017

Conditions

Keywords

Exercise Movement TechniquesLow Back PainExercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The change in Visual Analog Scale for Pain (VAS)

    At the first session and 5 weeks after the intervention

  • The change in The Functional Movement Screen (FMS)

    At the first session and 5 weeks after the intervention

Study Arms (2)

Stabilization

EXPERIMENTAL

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

Mobilization

EXPERIMENTAL

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

Interventions

10 sessions will be held twice a week, with each session taking an average of 50 minutes.

Mobilization

10 sessions will be held twice a week, with each session taking an average of 50 minutes.

Stabilization

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

Location

Related Publications (6)

  • 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.

    PMID: 22464116BACKGROUND
  • 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.

    PMID: 21522216BACKGROUND
  • 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.

    PMID: 21522225BACKGROUND
  • 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.

    PMID: 26777566BACKGROUND
  • 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.

    PMID: 24346291BACKGROUND
  • 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.

    PMID: 17304141BACKGROUND

MeSH Terms

Conditions

Low Back PainPainMotor Activity

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jefferson F Loss, PhD

    Federal University of Rio Grande do Sul

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 18, 2017

First Posted

June 15, 2017

Study Start

June 1, 2017

Primary Completion

October 30, 2017

Study Completion

January 20, 2018

Last Updated

December 7, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations