Lumbar Disc Herniation.Phase 1NCT01236924
Effectiveness of Global Postural Reeducation in Patients With Chronic Symptomatic Lumbar Disc Herniation
A Phase 1 study testing Global postural reeducation in people with Lumbar Disc Herniation., run by Universidade Gama Filho at 1 site in Brazil.
Trial summary
Slipped disc is the rupture of the fibrous ring, with subsequent displacement of the nucleus pulposus in intervertebral spaces, which may cause compression of nerve structures. It is estimated that 2-3% of the population have taken with this process, whose prevalence is 4.8% in men and 2.5% in women over 35 years. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men only
- Conditions the study is for
- Lumbar Disc Herniation.
- What is being tested?
- Global postural reeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to not given
- 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 25 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with chronic symptomatic lumbar disc herniation
Who cannot join
- Patients who work with severe overloading of the spine, patients with central neurological pathology, wheelchair users, patients who use bracing and support those who submit two consecutive absences to the treatment
Trial locations and contacts
1 site in 1 country.
About this study
Slipped disc is the rupture of the fibrous ring, with subsequent displacement of the nucleus pulposus in intervertebral spaces, which may cause compression of nerve structures. It is estimated that 2-3% of the population have taken with this process, whose prevalence is 4.8% in men and 2.5% in women over 35 years. Thus, the purpose of this study is to verify the effectiveness of global postural reeducation in patients diagnosed with chronic symptomatic lumbar disc herniation with the application of a randomized controlled trial. Will be measured pain, disability and functional flexibility.
- Conditions
- Lumbar Disc Herniation.
- Being tested
- Global postural reeducation
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global postural reeducationOther
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Not described Receives: Other: Global postural reeducation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc Herniation.Studies 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
Sponsor and investigators
- Lead sponsor
- Universidade Gama Filho
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236924
- Sponsor's protocol ID
- 112.2010
- Status last verified
- Nov 2010
- First submitted
- 8 Nov 2010
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Global Postural Reeducation in Patients With Chronic Symptomatic Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT01236924
- Acronym / sponsor ID
- 112.2010
- Conditions
- Lumbar Disc Herniation.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Universidade Gama FilhoUniversity, hospital or other
- Study start
- Jan 2011
- First posted
- 9 Nov 2010 (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.
Slipped disc is the rupture of the fibrous ring, with subsequent displacement of the nucleus pulposus in intervertebral spaces, which may cause compression of nerve structures. It is estimated that 2-3% of the population have taken with this process, whose prevalence is 4.8% in men and 2.5% in women over 35 years. Thus, the purpose of this study is to verify the effectiveness of global postural reeducation in patients diagnosed with chronic symptomatic lumbar disc herniation with the application of a randomized controlled trial. Will be measured pain, disability and functional flexibility.
Study design
- Primary purpose
- Treatment
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Other: Global postural reeducation |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients diagnosed with chronic symptomatic lumbar disc herniation
Key exclusion criteria (1 listed)
- Patients who work with severe overloading of the spine, patients with central neurological pathology, wheelchair users, patients who use bracing and support those who submit two consecutive absences to the treatment
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 reeducation | Other | Lifestyle counseling |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 reeducation in people with Lumbar Disc Herniation., run by Universidade Gama Filho 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 1 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 2010. 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?
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?
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.
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 2010.