Back PainGPRNCT01557049
Global Postural Reeducation in Chronic Low Back Pain
A study testing Global Reeducation Group in people with Back Pain and Mechanical Low Back Pain, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the effectiveness of a Global Postural Reeducation (GPR) program in subjects with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain, Mechanical Low Back Pain
- What is being tested?
- Global Reeducation Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2008to Feb 2012
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between 18-65 years age,
- low back pain (more than 12 weeks) without legs irradiation,
- pain between 3-8 cm on a visual Analogue scale (0-10cm).
Who cannot join
- fibromyalgia,
- pregnancy,
- osteoporosis severe,
- disc herniation,
- patients who had undergone spinal surgical or physiotherapeutic interventions within 3 months prior to baseline assessment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
São Paulo Federal University UNIFESP
São Paulo, São Paulo, 04023-900
About this study
Official title: Global Postural Reeducation in Chronic Low Back Pain: an Randomized Controlled Trial
The purpose of this study is to evaluate the effectiveness of a Global Postural Reeducation (GPR) program in subjects with chronic low back pain.
Read the detailed description
Approximately 80-85% of individuals will experience low back pain during their lifetime. It is one of the major concerns of current health care. There is evidence for the effectiveness of exercise therapy in patients with chronic low back pain. GPR is a physical therapy method developed in France by Philippe Emmanuel Souchard. Although this method is largely used as form of treatment in most countries, few studies showed its clinical effectiveness in chronic low back pain. This is the first randomized controlled trial, with assessor blind that evaluate the GPR effects in chronic low back pain. All outcome measurements are reliability, validated and sensitivity for statistical changes using the Visual Analogic Scale- VAS (0-10cm), Roland Morris Questionary, SF36 (Quality Life Questionary) and Beck Scale (Depression Symptoms).
- Conditions
- Back Pain, Mechanical Low Back Pain
- Being tested
- Control Group, Global Reeducation Group
- Keywords
- chronic low back pain, Postural global reeducation, randomized, physical rehabilitation
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
No physical intervention was given, patients were treated only with medication if necessary.
Global Reeducation GroupOther
They were treated with medication if necessary and performed GPR session once a week, during 12 weeks. All the 6 postures from GPR were used during the study.
| Study group | Role | What they receive |
|---|---|---|
| Postural Reeducation Group | Experimental | The participants, after obtaining a written informed consent, were randomized for one of the two groups: In the Global Postural Reeducation group (GPR), they were submitted 1 time per week, during 12 weeks, at GPR sessions. The duration of sessions was 60 minutes each, with the same physical Therapist of the study. After the intervention, subjects returned to assessment 3 months after, with the blinded assessor. All the 6 postures from GPR were used during the study. All outcomes measurements, in both groups, were validated for Portuguese language and applicable at baseline, 3 months and 6 months after baseline. Receives: Other: Global Reeducation Group |
| Control Group | No intervention | In the control group, no physical intervention was given during the study. After the study, 6 months after, all participants from control group received the same treatment given in GPR group, according to the Unifesp Ethics Committee orientations. All participants, of both groups, have a doctor from the study, if necessary. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain
The primary outcome of this study was the measurement of pain assessed with 0-10cm Visual Analogue Scale (VAS). They were collected at baseline and two follow-up examinations after 3 and 6 months from baseline.
Measured: baseline and two follow-up examinations - after 3 and 6 months from baseline
Secondary outcomes (1)
Change from baseline in function
The secondary outcome included function measured by Roland Morris Questionnaire. It was collected at baseline and two follow-up examinations after 3 and 6 months from baseline.
Measured: It was collected at baseline and two follow-up examinations after 3 and 6 months from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startJun 2008
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priscila Maria Mendonca de Almeida Lawand, Federal University of São Paulo
- Investigators
- Priscila Maria Lawand, Author, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557049
- Sponsor's protocol ID
- 1324/07
- Acronym
- GPR
- Status last verified
- Apr 2010
- First submitted
- 13 Mar 2012
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Postural Reeducation in Chronic Low Back Pain: an Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01557049
- Acronym / sponsor ID
- GPR / 1324/07
- Conditions
- Back Pain, Mechanical Low Back Pain
- Keywords
- chronic low back pain, Postural global reeducation, randomized, physical rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Mar 2012 (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 purpose of this study is to evaluate the effectiveness of a Global Postural Reeducation (GPR) program in subjects with chronic low back pain.
Detailed description
Approximately 80-85% of individuals will experience low back pain during their lifetime. It is one of the major concerns of current health care. There is evidence for the effectiveness of exercise therapy in patients with chronic low back pain. GPR is a physical therapy method developed in France by Philippe Emmanuel Souchard. Although this method is largely used as form of treatment in most countries, few studies showed its clinical effectiveness in chronic low back pain. This is the first randomized controlled trial, with assessor blind that evaluate the GPR effects in chronic low back pain. All outcome measurements are reliability, validated and sensitivity for statistical changes using the Visual Analogic Scale- VAS (0-10cm), Roland Morris Questionary, SF36 (Quality Life Questionary) and Beck Scale (Depression Symptoms).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postural Reeducation Group | Experimental | Other: Global Reeducation GroupThe participants, after obtaining a written informed consent, were randomized for one of the two groups: In the Global Postural Reeducation group (GPR), they were submitted 1 time per week, during 12 weeks, at GPR sessions. The duration of sessions was 60 minutes each, with the same physical Therapist of the study. After the intervention, subjects returned to assessment 3 months after, with the blinded assessor. All the 6 postures from GPR were used during the study. All outcomes measurements, in both groups, were validated for Portuguese language and applicable at baseline, 3 months and 6 months after baseline. |
| Control Group | No intervention | Other: Control GroupIn the control group, no physical intervention was given during the study. After the study, 6 months after, all participants from control group received the same treatment given in GPR group, according to the Unifesp Ethics Committee orientations. All participants, of both groups, have a doctor from the study, if necessary. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between 18-65 years age,
- low back pain (more than 12 weeks) without legs irradiation,
- pain between 3-8 cm on a visual Analogue scale (0-10cm).
Key exclusion criteria (5 listed)
- fibromyalgia,
- pregnancy,
- osteoporosis severe,
- disc herniation,
- patients who had undergone spinal surgical or physiotherapeutic interventions within 3 months prior to baseline assessment.
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 |
|---|---|---|
| Control GroupNo physical intervention was given, patients were treated only with medication if necessary. | Other | Control Group |
| Global Reeducation GroupThey were treated with medication if necessary and performed GPR session once a week, during 12 weeks. All the 6 postures from GPR were used during the study. | Other | Postural Reeducation Group |
Primary outcome
Change from baseline in pain
Time frame: baseline and two follow-up examinations - after 3 and 6 months from baseline
The primary outcome of this study was the measurement of pain assessed with 0-10cm Visual Analogue Scale (VAS). They were collected at baseline and two follow-up examinations after 3 and 6 months from baseline.
1 secondary outcome
Change from baseline in function
Time frame: It was collected at baseline and two follow-up examinations after 3 and 6 months from baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
- Postural Global Reeducation SocietyLink provided by the sponsor.
- São Paulo Federal UniversityLink provided by the sponsor.
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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.
Priscila Maria Lawand, Author principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global Reeducation Group in people with Back Pain and Mechanical Low Back Pain, run by Federal University of São Paulo 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 19 Mar 2012. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in pain (time frame: baseline and two follow-up examinations - after 3 and 6 months from baseline). 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 19 Mar 2012.