Low Back PainEarly Phase 1NCT01468298
Global Posture Reeducation (GPR) Compared To Isostretching in Chronic Low Back Pain Patients
A Early Phase 1 study testing Isostretching and Global Posture Reeducation in people with Low Back Pain, run by Centro Universitario de Maringa at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Isostretching and Global Posture Reeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Dec 2011
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with non-specific LBP in its chronic phase (pain lasting more than 12 weeks), from 40 to 60 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Global Posture Reeducation With Isostretching in Chronic Low Back Pain Patients
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Isostretching, Global Posture Reeducation
- Keywords
- back pain, physical therapy, spine, rehabilitation, exercise
- Medical subject headings
- Low Back Pain, Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsostretchingOther
Also called postural reeducation
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.
Global Posture ReeducationOther
Also called postural 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.
| Study group | Role | What they receive |
|---|---|---|
| Isostretching | Active comparator | Not described Receives: Other: Isostretching |
| Global Posture Reeducation | Active comparator | Not described Receives: Other: Global Posture Reeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional capacity
Low back patients functional capacity were evaluated before and after 10 sesssions treatment regarding by Rolland-Morris Questionnaire.
Measured: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
Secondary outcomes (8)
Posture
Posture were evaluated before and after 10 sessions treatment regarding posture by computer SAPO (Softwere Avaluation Posture Online) program.
Measured: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
flexibility
These were evaluated before and after 10 sessions treatment regarding posture, flexibility for lumbar Schober testing and sit and reach.
Measured: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
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.
Measured: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
heart rate(HR)
It was measured heart rate (HR)by polar frequencymetric at start and for every 15 minutes in 10 sessions therapy.
Measured: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
peripheral oxygen saturation
It was measured peripheral oxygen saturation (SpO2) by Finger Pulse Oximeter at start and for every 15 minutes in therapy.
Measured: 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..
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).
Measured: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks..
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).
Measured: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
Intensity of Pain
The low back intensity of pain were evaluated before and after 10 sessions treatment regarding pain by visual analog scale.
Measured: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startAug 2010
- Primary completionOct 2011
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Maringa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ligia Maria Facci, Centro Universitario de Maringa
- Investigators
- Ligia M Facci, doctor, Principal investigator, Centro Universitario de Maringa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468298
- Sponsor's protocol ID
- 249/2010
- Status last verified
- Oct 2011
- First submitted
- 25 Oct 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Global Posture Reeducation With Isostretching in Chronic Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT01468298
- Acronym / sponsor ID
- 249/2010
- Conditions
- Low Back Pain
- Keywords
- back pain, physical therapy, spine, rehabilitation, exercise
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centro Universitario de MaringaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (estimated)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isostretching | Active comparator | Other: Isostretching |
| Global Posture Reeducation | Active comparator | Other: Global Posture Reeducation |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with non-specific LBP in its chronic phase (pain lasting more than 12 weeks), from 40 to 60 years old.
Key exclusion criteria (8 listed)
- scheduling conflicts
- lack of transportation
- disease that compromises their health during the treatment
- uncontrolled hypertension
- fibromyalgia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsostretchingAlso: postural reeducationAll 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 | Isostretching |
| Global Posture ReeducationAlso: postural reeducationAll 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 | Global Posture Reeducation |
Primary outcome
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.
8 secondary outcomes
Posture
Time frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
flexibility
Time frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
muscle strength
Time frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
heart rate(HR)
Time frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
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..
systolic blood pressure
Time frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks..
diastolic blood pressure
Time frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
Intensity of Pain
Time frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ligia M Facci, doctor principal investigator
Centro Universitario de Maringa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Isostretching and Global Posture Reeducation in people with Low Back Pain, run by Centro Universitario de Maringa at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional capacity (time frame: Patients will be followed for the duration of 10 sessions, an expected average of 5 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2011.