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

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ClinicalTrials.gov Identifier: NCT01468298
Recruitment Status : Unknown
Verified October 2011 by Ligia Maria Facci, Centro Universitario de Maringa.
Recruitment status was:  Active, not recruiting
First Posted : November 9, 2011
Last Update Posted : November 9, 2011
Sponsor:
Information provided by (Responsible Party):
Ligia Maria Facci, Centro Universitario de Maringa

Tracking Information
First Submitted Date  ICMJE October 25, 2011
First Posted Date  ICMJE November 9, 2011
Last Update Posted Date November 9, 2011
Study Start Date  ICMJE August 2010
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2011)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Global Posture Reeducation (GPR) Compared To Isostretching in Chronic Low Back Pain Patients
Official Title  ICMJE Comparing the Global Posture Reeducation With Isostretching in Chronic Low Back Pain Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Isostretching
    Intervention: Other: Isostretching
  • Active Comparator: Global Posture Reeducation
    Intervention: Other: Global Posture Reeducation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 7, 2011)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01468298
Other Study ID Numbers  ICMJE 249/2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ligia Maria Facci, Centro Universitario de Maringa
Study Sponsor  ICMJE Centro Universitario de Maringa
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ligia M Facci, doctor Centro Universitario de Maringa
PRS Account Centro Universitario de Maringa
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP