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

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Early Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Isostretching
Global Posture Reeducation
Sponsored by
Centro Universitario de Maringa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring back pain, physical therapy, spine, rehabilitation, exercise

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centro Universitário de Maringá

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Isostretching

Global Posture Reeducation

Arm Description

Outcomes

Primary Outcome Measures

functional capacity
Low back patients functional capacity were evaluated before and after 10 sesssions treatment regarding by Rolland-Morris Questionnaire.

Secondary Outcome Measures

Posture
Posture were evaluated before and after 10 sessions treatment regarding posture by computer SAPO (Softwere Avaluation Posture Online) program.
flexibility
These were evaluated before and after 10 sessions treatment regarding posture, flexibility for lumbar Schober testing and sit and reach.
muscle strength
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.
heart rate(HR)
It was measured heart rate (HR)by polar frequencymetric at start and for every 15 minutes in 10 sessions therapy.
peripheral oxygen saturation
It was measured peripheral oxygen saturation (SpO2) by Finger Pulse Oximeter at start and for every 15 minutes in therapy.
systolic blood pressure
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).
diastolic blood pressure
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).
Intensity of Pain
The low back intensity of pain were evaluated before and after 10 sessions treatment regarding pain by visual analog scale.

Full Information

First Posted
October 25, 2011
Last Updated
November 7, 2011
Sponsor
Centro Universitario de Maringa
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1. Study Identification

Unique Protocol Identification Number
NCT01468298
Brief Title
Global Posture Reeducation (GPR) Compared To Isostretching in Chronic Low Back Pain Patients
Official Title
Comparing the Global Posture Reeducation With Isostretching in Chronic Low Back Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitario de Maringa

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
back pain, physical therapy, spine, rehabilitation, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Isostretching
Arm Type
Active Comparator
Arm Title
Global Posture Reeducation
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Isostretching
Other Intervention Name(s)
postural reeducation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Global Posture Reeducation
Other Intervention Name(s)
postural reeducation
Intervention Description
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.
Primary Outcome Measure Information:
Title
functional capacity
Description
Low back patients functional capacity were evaluated before and after 10 sesssions treatment regarding by Rolland-Morris Questionnaire.
Time Frame
Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
Secondary Outcome Measure Information:
Title
Posture
Description
Posture were evaluated before and after 10 sessions treatment regarding posture by computer SAPO (Softwere Avaluation Posture Online) program.
Time Frame
Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
Title
flexibility
Description
These were evaluated before and after 10 sessions treatment regarding posture, flexibility for lumbar Schober testing and sit and reach.
Time Frame
Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
Title
muscle strength
Description
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.
Time Frame
Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
Title
heart rate(HR)
Description
It was measured heart rate (HR)by polar frequencymetric at start and for every 15 minutes in 10 sessions therapy.
Time Frame
Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
Title
peripheral oxygen saturation
Description
It was measured peripheral oxygen saturation (SpO2) by Finger Pulse Oximeter at start and for every 15 minutes in therapy.
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..
Title
systolic blood pressure
Description
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).
Time Frame
Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks..
Title
diastolic blood pressure
Description
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).
Time Frame
Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
Title
Intensity of Pain
Description
The low back intensity of pain were evaluated before and after 10 sessions treatment regarding pain by visual analog scale.
Time Frame
Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ligia M Facci, doctor
Organizational Affiliation
Centro Universitario de Maringa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Universitário de Maringá
City
Maringá
State/Province
Paraná
ZIP/Postal Code
87050390
Country
Brazil

12. IPD Sharing Statement

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

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