Global Posture Reeducation (GPR) Compared To Isostretching in Chronic Low Back Pain Patients

November 7, 2011 updated by: Ligia Maria Facci, Centro Universitario de Maringa

Comparing the Global Posture Reeducation With Isostretching in Chronic Low Back Pain Patients

The aim of this study was to investigate the changes in posture, flexibility, muscle strength, functional capacity, heart rate(HR), peripheral oxygen saturation, systolic blood pressure, diastolic blood pressure and intensity of pain in chronic low back pain underwent to Isostretching and GPR.

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.

Detailed Description

It was selected 40 patients, from 40 to 59 years old, with chronic low back pain from CESUMAR Physiotherapy Clinic-Schoo. These were evaluated before and after treatment regarding posture by SAPO computer program; flexibility for lumbar Schober testing, sit and reach; muscle strength by dynamometry for trunk extensors and the maximum repetition test in a minute to abdominal and trunk extensors; functional capacity by Rolland-Morris Questionnaire; pain by visual analog scale; heart rate(HR) by polar frequencymetric; peripheral oxygen saturation by Finger Pulse Oximeter; and systolic and diastolic blood pressure with a Sphygmomanometer. The sample was divided in two groups (1-GPR with 11 patients, 2-Isostretching with 10 patients). All patients were accompanied by an individual treatment program composed by 12 sessions of 45 minutes, twice a week. It was considered statistically significant p values <0.05 obtained from the Student's t test.

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 (Anticipated)

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.
40

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.
  • Early Phase 1

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
    • Paraná
      • Maringá, Paraná, Brazil, 87050390
        • Centro Universitário de Maringá

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

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with non-specific LBP in its chronic phase (pain lasting more than 12 weeks), from 40 to 60 years old.

Exclusion Criteria:

  • scheduling conflicts
  • lack of transportation
  • disease that compromises their health during the treatment
  • uncontrolled hypertension
  • fibromyalgia
  • history of spinal surgery in the last six months
  • patients with neurological diseases
  • individuals who demonstrate inability to understand or physical restraint for the exercises.

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
  • Masking: SINGLE

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.
Active Comparator: Isostretching
Other: Isostretching
All of patients were accompanied by an individual treatment program composed by 12 sessions of 45 minutes, twice a week. The Isostretching method includes therapeutic different postures, lying, sitting or standing, and the positions were selected according to the postural changes of each patient, identified in the assessment. The Isostretching protocol involves nine positions held for a period of nine breaths, and every three cycles, the patient should rest for a period. The physical therapist used verbal commands to emphasize pursed lip breathing, self growth, curvatures correction and isometric of abdominal, paravertebral, quadriceps and gluteal muscles with the aim of optimizing the stretching and discouraging compensatory movements.
Other Names:
  • postural reeducation
Active Comparator: Global Posture Reeducation
Other: Global Posture Reeducation
All patients were accompanied by an individual treatment program composed by 12 sessions of 45 minutes, twice a week, involving a series of active gentle movements and postures aimed at realigning joints, stretching shortened muscles and enhancing the contraction of antagonist muscles, thus avoiding postural asymmetry. The positions were selected according to the postural changes of each patient, identified in the assessment and these therapeutic postures imply an active involvement of the patient. The protocol includes three therapeutic postures, lying, sitting or standing, to be held for 15 minutes each. The physical therapist used verbal commands and manual contact to maintain the alignment and make the necessary postural corrections, with the aim of discouraging compensatory movements.
Other Names:
  • postural reeducation

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
functional capacity
Time Frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
Low back patients functional capacity were evaluated before and after 10 sesssions treatment regarding by Rolland-Morris Questionnaire.
Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.

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
Posture
Time Frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
Posture were evaluated before and after 10 sessions treatment regarding posture by computer SAPO (Softwere Avaluation Posture Online) program.
Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
flexibility
Time Frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
These were evaluated before and after 10 sessions treatment regarding posture, flexibility for lumbar Schober testing and sit and reach.
Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
muscle strength
Time Frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
These were evaluated before and after 10 sessions treatment regarding muscle strength by dynamometry for trunk extensors and the maximum repetition test in a minute to abdominal and trunk extensors.
Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
heart rate(HR)
Time Frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
It was measured heart rate (HR)by polar frequencymetric at start and for every 15 minutes in 10 sessions therapy.
Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
peripheral oxygen saturation
Time Frame: Before and after 10 sessions and for every 15 minutes in therapyPatients will be followed for the duration of 10 sessions, an expected average of 5 weeks..
It was measured peripheral oxygen saturation (SpO2) by Finger Pulse Oximeter at start and for every 15 minutes in therapy.
Before and after 10 sessions and for every 15 minutes in therapyPatients will be followed for the duration of 10 sessions, an expected average of 5 weeks..
systolic blood pressure
Time Frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks..
It was measured systolic blood pressure (SBP) with a Sphygmomanometer at start and for every 15 minutes in 10 sessions therapy. Blood pressure measurement was obtained by arterial occlusion by inflation of the cuff, correlating to the auscultation of the heartbeat with the values recorded in the column of mercury. The sounds perceived during the blood pressure measurement procedure are called Korotkoff sounds, and classified into five phases, with phase 1 (first sound) corresponding to the value of systolic blood pressure (SBP).
Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks..
diastolic blood pressure
Time Frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
It was measured diastolic blood pressure (DBP) with a Sphygmomanometer at start and for every 15 minutes in 10 sessions therapy.Blood Ppressure measurement was obtained by arterial occlusion by inflation of the cuff, correlating to the auscultation of the heartbeat with the values recorded in the column of mercury. The sounds perceived during the blood pressure measurement procedure are called Korotkoff sounds, and classified into five phases, with phase 5 (muffling or disappearance of sound) corresponding value of diastolic blood pressure (DBP).
Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
Intensity of Pain
Time Frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
The low back intensity of pain were evaluated before and after 10 sessions treatment regarding pain by visual analog scale.
Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.

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.
Centro Universitario de Maringa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ligia M Facci, doctor, Centro Universitário de Maringá

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

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.
August 1, 2010

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 1, 2011

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.
December 1, 2011

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).
October 25, 2011

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.
November 7, 2011

First Posted (Estimate)

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.
November 9, 2011

Study Record Updates

Last Update Posted (Estimate)

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.
November 9, 2011

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.
November 7, 2011

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.
October 1, 2011

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.
  • 249/2010

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