Spinal Stenosis of Lumbar RegionNCT01456377
The Effectiveness of Oral Corticosteroids in the Treatment of Lumbar Stenosis
A study testing predinose oral in people with Spinal Stenosis of Lumbar Region, run by Federal University of São Paulo at 2 sites in Brazil.
Trial summary
The aim of this study is to evaluate the effectiveness of the use of systemic corticosteroids administered orally in narrow lumbar canal syndrome. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Spinal Stenosis of Lumbar Region
- What is being tested?
- predinose oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesBrazil
- Study dates
- Jul 2011to Jun 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low back pain and at least two of the following complaints in lower limbs: pain, weakness, burning or numbness that worsens with walking and improves with the cessation of walking.
Who cannot join
- decompensated diabetes mellitus.
- Systemic hypertension and decompensated heart
- systemic disease affecting the lower limbs
- Neuromuscular Disease
- Use of steroids in the past 3 months.
- Patients with previous surgery of the thoracic or lumbar spine.
Show all 9Show fewer
- cognitive disorder that interferes with the ability to understand or interpret the questionnaires
- Spondylolisthesis except degenerative
- degenerative scoliosis with Cobb angle of 10 °
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Santa Marcelina Hospital
São Paulo, São Paulo, 08270-070
edna L Ohana, secretary, 551120706317, ednaohana@ig.com.br
Jamil Natour, Doctor
- Recruiting
Santa Mareclina Hospital
São Paulo, São Paulo, 08270-070
Luiz Claudio L Rodrigues, docctor, 551120706317, luizclr@terra.com.br
About this study
Official title: A Prospective Controlled Study Randomized Double Blind Study, Evaluate the Effectiveness of Oral Corticosteroids in the Treatment of Stenosis of Lumbar Canal In Symptomatic Patients
The aim of this study is to evaluate the effectiveness of the use of systemic corticosteroids administered orally in narrow lumbar canal syndrome.
Read the detailed description
60 patients are being randomized, plank by randomization, the patient and the examiner will be blinded. Will be placed in opaque brown envelopes in order to maintain the secrecy of allocation.
Included patients aged between 50 and 75 years of both sexes participate in the work to accept and sign the Informed Consent The patient will be screened in advance after the acceptance of it will be an anthropometric assessment, with assessment of height, weight and presence of associated comorbidities.
After clinical evaluation they headed for the initial evaluation, after this evaluation, patients are randomized and and delivered to the patient the medication with corticosteroids or placebo for an unrelated medical research. It is also given a bottle of paracetamol 750 mg and a sheet dated, in which the patient is instructed to register the day this sheet and number of capsules taken, which is also an evaluation factor.
evaluation VAS SF 36 Roland Morris questionnaire Test 6-minute walk Likert scale ELegibility Criteria
Clinical diagnosis:
Low back pain and at least two of the following complaints in lower limbs: pain, weakness, burning or numbness that worsens with walking and improves with the cessation of walking.
Radiological diagnosis:
Presence of lumbar canal stenosis with an area less than 100mm2 Hamanishi based on criteria measured at lumbar spine MRI in the follow-up from L1 to S1.
- Conditions
- Spinal Stenosis of Lumbar Region
- Being tested
- predinose oral, placebo group
- Keywords
- lumbar stenosis, systemic corticosteroids, outcome, security
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
predinose oralDrug
1 mg for kg for 3 wekees
placebo groupDrug
use a oral placebo
| Study group | Role | What they receive |
|---|---|---|
| corticosteroids, analgesics oral pill | Active comparator | Oral Corticosteroids and oral analgesics Receives: Drug: predinose oral |
| placebo | Placebo comparator | oral placebo and oral analgesics Receives: Drug: placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of oral corticosteroids in the treatment of spinal stenosis
The aim of this study is to evaluate the effectiveness of the use of systemic corticosteroids administered orally in narrow lumbar stenosis.
use SF-36 VAS roland Moris questionnaire
Measured: 3 months
Secondary outcomes (1)
effectiveness and security of oral corticosteroids in the treatment of spinal stenosis
assess the safety of oral corticosteroids in patients with spinal stenosis and tolerability of patients with this medication control of sistemic diseases and safety with oral corticosteroids evaluation for osteoporotic patients in use of oral costicosteroids SF-36 VAS Roland Moris questionnaire 6 minuts walk test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis of Lumbar RegionStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Claudio Lacerda Rodrigues, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456377
- Sponsor's protocol ID
- 1892/10
- Status last verified
- Oct 2011
- First submitted
- 12 Oct 2011
- Last updated
- 20 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Controlled Study Randomized Double Blind Study, Evaluate the Effectiveness of Oral Corticosteroids in the Treatment of Stenosis of Lumbar Canal In Symptomatic Patients
- ClinicalTrials.gov ID
- NCT01456377
- Acronym / sponsor ID
- 1892/10
- Conditions
- Spinal Stenosis of Lumbar Region
- Keywords
- lumbar stenosis, systemic corticosteroids, outcome, security
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 20 Oct 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 is to evaluate the effectiveness of the use of systemic corticosteroids administered orally in narrow lumbar canal syndrome.
Detailed description
60 patients are being randomized, plank by randomization, the patient and the examiner will be blinded. Will be placed in opaque brown envelopes in order to maintain the secrecy of allocation.
Included patients aged between 50 and 75 years of both sexes participate in the work to accept and sign the Informed Consent The patient will be screened in advance after the acceptance of it will be an anthropometric assessment, with assessment of height, weight and presence of associated comorbidities.
After clinical evaluation they headed for the initial evaluation, after this evaluation, patients are randomized and and delivered to the patient the medication with corticosteroids or placebo for an unrelated medical research. It is also given a bottle of paracetamol 750 mg and a sheet dated, in which the patient is instructed to register the day this sheet and number of capsules taken, which is also an evaluation factor.
evaluation VAS SF 36 Roland Morris questionnaire Test 6-minute walk Likert scale ELegibility Criteria
Clinical diagnosis:
Low back pain and at least two of the following complaints in lower limbs: pain, weakness, burning or numbness that worsens with walking and improves with the cessation of walking.
Radiological diagnosis:
Presence of lumbar canal stenosis with an area less than 100mm2 Hamanishi based on criteria measured at lumbar spine MRI in the follow-up from L1 to S1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| corticosteroids, analgesics oral pill | Active comparator | Drug: predinose oralOral Corticosteroids and oral analgesics |
| placebo | Placebo comparator | Drug: placebo grouporal placebo and oral analgesics |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Low back pain and at least two of the following complaints in lower limbs: pain, weakness, burning or numbness that worsens with walking and improves with the cessation of walking.
Key exclusion criteria (9 listed)
- decompensated diabetes mellitus.
- Systemic hypertension and decompensated heart
- systemic disease affecting the lower limbs
- Neuromuscular Disease
- Use of steroids in the past 3 months.
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 |
|---|---|---|
| predinose oral1 mg for kg for 3 wekees | Drug | corticosteroids, analgesics oral pill |
| placebo groupuse a oral placebo | Drug | placebo |
Primary outcome
effectiveness of oral corticosteroids in the treatment of spinal stenosis
Time frame: 3 months
The aim of this study is to evaluate the effectiveness of the use of systemic corticosteroids administered orally in narrow lumbar stenosis. use SF-36 VAS roland Moris questionnaire
1 secondary outcome
effectiveness and security of oral corticosteroids in the treatment of spinal stenosis
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing predinose oral in people with Spinal Stenosis of Lumbar Region, run by Federal University of São Paulo at 2 sites 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 9 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 20 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luiz Claudio l Rodrigues, doctor (551120706317, luizclr@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of oral corticosteroids in the treatment of spinal stenosis (time frame: 3 months). 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 20 Oct 2011.