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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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