NCT01468298

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 9, 2011

Status Verified

October 1, 2011

Enrollment Period

1.2 years

First QC Date

October 25, 2011

Last Update Submit

November 7, 2011

Conditions

Keywords

back painphysical therapyspinerehabilitationexercise

Outcome Measures

Primary Outcomes (1)

  • functional capacity

    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 Outcomes (8)

  • Posture

    Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.

  • flexibility

    Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.

  • muscle strength

    Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.

  • heart rate(HR)

    Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.

  • peripheral oxygen saturation

    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..

  • +3 more secondary outcomes

Study Arms (2)

Isostretching

ACTIVE COMPARATOR
Other: Isostretching

Global Posture Reeducation

ACTIVE COMPARATOR
Other: Global Posture Reeducation

Interventions

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.

Also known as: postural reeducation
Isostretching

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.

Also known as: postural reeducation
Global Posture Reeducation

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Universitário de Maringá

Maringá, Paraná, 87050390, Brazil

Location

MeSH Terms

Conditions

Low Back PainBack PainMotor Activity

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Ligia M Facci, doctor

    Centro Universitario de Maringa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

October 25, 2011

First Posted

November 9, 2011

Study Start

August 1, 2010

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

November 9, 2011

Record last verified: 2011-10

Locations