Low Back PainPhase 1NCT00789204
Postural Re-education in Low Back Pain
A Phase 1 study testing Global Postural Re-education and Standard Exercise Training in people with Low Back Pain, run by University of Bologna at 1 site in Italy.
Trial summary
The Global Postural Re-Education is a global approach for the treatment of musculoskeletal disease. Using specific progressive posture for stretching particular shortened chain muscle the method wants to equilibrate the never-ending war between static and dynamic muscles by guiding the patient in a particular… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Global Postural Re-education and Standard Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- May 2008to Sep 2009
- Phase
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lumbalgia Diagnosis
- Age 18-80
Who cannot join
- Migrated hernia
- Calcified disc hernia
- Spondylolisthesis
- Other physiotherapeutic interventions within 6 months of the baseline assessment.
- Surgical operation within six months of baseline
- Cancer syndrome, Neurological and rheumatic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a "Global Posture Reeducation" Program for Patients With Low Back Pain
The Global Postural Re-Education is a global approach for the treatment of musculoskeletal disease. Using specific progressive posture for stretching particular shortened chain muscle the method wants to equilibrate the never-ending war between static and dynamic muscles by guiding the patient in a particular breathing pattern to maintain a correct posture and feeling it.
Read the detailed description
In some countries there is a physical therapy method called "Global Posture Reeducation" (GPR), which was developed by Philippe Emmanuel Souchard based on 20 years of clinical experience.The method consist to balance the miofascial tension probably responsible for an articular overloading. The method stretches the shortened antigravity muscles that are inside a different static muscles chains. GPR is a global approach that search the biomechanics cause in the near areas, and involves actively the patient in the postural and gestural changes.
- Conditions
- Low Back Pain
- Being tested
- Global Postural Re-education, Standard Exercise Training
- Keywords
- exercise, low back pain, posture, rehabilitation
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Postural Re-educationOther
Also called GPR
The treatment in Global Postural Re-education is a global approach that seeks to identify the biomechanical cause of the problem also in other parts of the body and involves actively the patient in the postural change. Using principles like causality, globality and individuality, the treatment consists of the use for one hour of progressive active stretching posture for specific muscular chain that are shortened. Every posture is maintained for 20 minutes with controlled breathing and the use of manual traction
Standard Exercise TrainingOther
Also called SEP
The exercise programme included passive lumbar flexion, pelvic tilt, strengthening of flexor muscles, strengthening of extensor muscles, spine mobilization and stretching exercises.
| Study group | Role | What they receive |
|---|---|---|
| GPR | Experimental | Global Postural Re-Education Receives: Other: Global Postural Re-education |
| SEP | Active comparator | Standard Exercise Programm Receives: Other: Standard Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland & Morris Disability Questionnaire
Measured: Baseline, 3 months, 6 months
Secondary outcomes (3)
Oswestry Disability Index
Measured: Baseline, 3 months, 6 months
Pain Drawing and Visual Analogue Scale (V.A.S.)
Measured: Baseline, 3 mounths, 6 months
Fingertip-to-floor test
Measured: Baseline, 3 mounths, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Investigators
- Francesca Bonetti, Laurea, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789204
- Sponsor's protocol ID
- FB001022008
- Status last verified
- Sep 2009
- First submitted
- 10 Nov 2008
- Last updated
- 22 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Vanti C, Generali A, Ferrari S, Nava T, Tosarelli D, Pillastrini P. [ General postural rehabilitation in musculoskeletal diseases: scientific evidence and clinical indications]. Reumatismo. 2007 Jul-Sep;59(3):192-201. Italian.
PubMed 17898878Fernandez-de-Las-Penas C, Alonso-Blanco C, Morales-Cabezas M, Miangolarra-Page JC. Two exercise interventions for the management of patients with ankylosing spondylitis: a randomized controlled trial. Am J Phys Med Rehabil. 2005 Jun;84(6):407-19. doi: 10.1097/01.phm.0000163862.89217.fe.
PubMed 15905654Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD000335. doi: 10.1002/14651858.CD000335.pub2.
PubMed 16034851Bonetti F, Curti S, Mattioli S, Mugnai R, Vanti C, Violante FS, Pillastrini P. Effectiveness of a 'Global Postural Reeducation' program for persistent low back pain: a non-randomized controlled trial. BMC Musculoskelet Disord. 2010 Dec 16;11:285. doi: 10.1186/1471-2474-11-285.
PubMed 21162726
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a "Global Posture Reeducation" Program for Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT00789204
- Acronym / sponsor ID
- FB001022008
- Conditions
- Low Back Pain
- Keywords
- exercise, low back pain, posture, rehabilitation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Nov 2008 (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 Global Postural Re-Education is a global approach for the treatment of musculoskeletal disease. Using specific progressive posture for stretching particular shortened chain muscle the method wants to equilibrate the never-ending war between static and dynamic muscles by guiding the patient in a particular breathing pattern to maintain a correct posture and feeling it.
Detailed description
In some countries there is a physical therapy method called "Global Posture Reeducation" (GPR), which was developed by Philippe Emmanuel Souchard based on 20 years of clinical experience.The method consist to balance the miofascial tension probably responsible for an articular overloading. The method stretches the shortened antigravity muscles that are inside a different static muscles chains. GPR is a global approach that search the biomechanics cause in the near areas, and involves actively the patient in the postural and gestural changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GPR | Experimental | Other: Global Postural Re-educationGlobal Postural Re-Education |
| SEP | Active comparator | Other: Standard Exercise TrainingStandard Exercise Programm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Lumbalgia Diagnosis
- Age 18-80
Key exclusion criteria (6 listed)
- Migrated hernia
- Calcified disc hernia
- Spondylolisthesis
- Other physiotherapeutic interventions within 6 months of the baseline assessment.
- Surgical operation within six months of baseline
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 |
|---|---|---|
| Global Postural Re-educationAlso: GPRThe treatment in Global Postural Re-education is a global approach that seeks to identify the biomechanical cause of the problem also in other parts of the body and involves actively the patient in the postural change. Using principles like causality, globality and individuality, the treatment consists of the use for one hour of progressive active stretching posture for specific muscular chain that are shortened. Every posture is maintained for 20 minutes with controlled breathing and the use of manual traction | Other | GPR |
| Standard Exercise TrainingAlso: SEPThe exercise programme included passive lumbar flexion, pelvic tilt, strengthening of flexor muscles, strengthening of extensor muscles, spine mobilization and stretching exercises. | Other | SEP |
Primary outcome
Roland & Morris Disability Questionnaire
Time frame: Baseline, 3 months, 6 months
3 secondary outcomes
Oswestry Disability Index
Time frame: Baseline, 3 months, 6 months
Pain Drawing and Visual Analogue Scale (V.A.S.)
Time frame: Baseline, 3 mounths, 6 months
Fingertip-to-floor test
Time frame: Baseline, 3 mounths, 6 months
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 22 Sep 2009.
- Background: PubMed 17898878Vanti C, Generali A, Ferrari S, Nava T, Tosarelli D, Pillastrini P. [ General postural rehabilitation in musculoskeletal diseases: scientific evidence and clinical indications]. Reumatismo. 2007 Jul-Sep;59(3):192-201. Italian.
- Background: PubMed 15905654Fernandez-de-Las-Penas C, Alonso-Blanco C, Morales-Cabezas M, Miangolarra-Page JC. Two exercise interventions for the management of patients with ankylosing spondylitis: a randomized controlled trial. Am J Phys Med Rehabil. 2005 Jun;84(6):407-19. doi: 10.1097/01.phm.0000163862.89217.fe.
- Background: PubMed 16034851Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD000335. doi: 10.1002/14651858.CD000335.pub2.
- Derived from this study: PubMed 21162726Bonetti F, Curti S, Mattioli S, Mugnai R, Vanti C, Violante FS, Pillastrini P. Effectiveness of a 'Global Postural Reeducation' program for persistent low back pain: a non-randomized controlled trial. BMC Musculoskelet Disord. 2010 Dec 16;11:285. doi: 10.1186/1471-2474-11-285.
Related trials for Low Back Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
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.
Francesca Bonetti, Laurea principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Global Postural Re-education and Standard Exercise Training in people with Low Back Pain, run by University of Bologna at 1 site in Italy.
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 2 inclusion and 6 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 22 Sep 2009. 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 Italy. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Roland & Morris Disability Questionnaire (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00789204, which also lists 4 linked publications.
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 22 Sep 2009.