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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Centro Universitario de Maringa.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Ligia Maria Facci, Centro Universitario de Maringa
ClinicalTrials.gov Identifier:
NCT01468298
First received: October 25, 2011
Last updated: November 7, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Other: Isostretching
Other: Global Posture Reeducation
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing the Global Posture Reeducation With Isostretching in Chronic Low Back Pain Patients

Resource links provided by NLM:


Further study details as provided by Centro Universitario de Maringa:

Primary Outcome Measures:
  • functional capacity [ Time Frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks. ] [ Designated as safety issue: Yes ]
    Low back patients functional capacity were evaluated before and after 10 sesssions treatment regarding by Rolland-Morris Questionnaire.


Secondary Outcome Measures:
  • Posture [ Time Frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks. ] [ Designated as safety issue: Yes ]
    Posture were evaluated before and after 10 sessions treatment regarding posture by computer SAPO (Softwere Avaluation Posture Online) program.

  • flexibility [ Time Frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks. ] [ Designated as safety issue: Yes ]
    These were evaluated before and after 10 sessions treatment regarding posture, flexibility for lumbar Schober testing and sit and reach.

  • muscle strength [ Time Frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks. ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks. ] [ Designated as safety issue: Yes ]
    It was measured heart rate (HR)by polar frequencymetric at start and for every 15 minutes in 10 sessions therapy.

  • 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.. ] [ Designated as safety issue: Yes ]
    It was measured peripheral oxygen saturation (SpO2) by Finger Pulse Oximeter at start and for every 15 minutes in therapy.

  • systolic blood pressure [ Time Frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks. ] [ Designated as safety issue: Yes ]
    The low back intensity of pain were evaluated before and after 10 sessions treatment regarding pain by visual analog scale.


Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: postural reeducation

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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01468298

Locations
Brazil
Centro Universitário de Maringá
Maringá, Paraná, Brazil, 87050390
Sponsors and Collaborators
Centro Universitario de Maringa
Investigators
Principal Investigator: Ligia M Facci, doctor Centro Universitario de Maringa
  More Information

No publications provided

Responsible Party: Ligia Maria Facci, Principal Investigator, Clinical Professor, Centro Universitario de Maringa
ClinicalTrials.gov Identifier: NCT01468298     History of Changes
Other Study ID Numbers: 249/2010
Study First Received: October 25, 2011
Last Updated: November 7, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Centro Universitario de Maringa:
back pain
physical therapy
spine
rehabilitation
exercise

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014