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

• ClinicalTrials.gov Identifier: NCT01468298
• Recruitment Status: Unknown
• First Posted: November 9, 2011
• Last Update Posted: November 9, 2011
• Sponsor: Centro Universitario de Maringa
• Information provided by (Responsible Party): Ligia Maria Facci, Centro Universitario de Maringa

Tracking Information

• First Submitted Date: October 25, 2011
• First Posted Date: November 9, 2011
• Last Update Posted Date: November 9, 2011
• Study Start Date: August 2010
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Low Back Pain

Intervention

• 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

• Active Comparator: Isostretching
  Intervention: Other: Isostretching
• Active Comparator: Global Posture Reeducation
  Intervention: Other: Global Posture Reeducation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 7, 2011): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2011
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01468298
• Other Study ID Numbers: 249/2010
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ligia Maria Facci, Centro Universitario de Maringa
• Study Sponsor: Centro Universitario de Maringa
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ligia M Facci, doctor; Centro Universitario de Maringa

• PRS Account: Centro Universitario de Maringa
• Verification Date: October 2011