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

December 5, 2017 updated by: Jefferson Fagundes Loss, Federal University of Rio Grande do Sul

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90690-200
        • Universidade Federal do Rio Grande do Sul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the first session and 5 weeks after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the first session and 5 weeks after the intervention
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.
At the first session and 5 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

October 30, 2017

Study Completion (Anticipated)

January 20, 2018

Study Registration Dates

First Submitted

May 18, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (Actual)

June 15, 2017

Study Record Updates

Last Update Posted (Actual)

December 7, 2017

Last Update Submitted That Met QC Criteria

December 5, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOB X STAB in Pilates

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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