The Effectiveness of Oral Corticosteroids in the Treatment of Lumbar Stenosis
Primary Purpose
Spinal Stenosis of Lumbar Region
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
predinose oral
placebo group
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Stenosis of Lumbar Region focused on measuring lumbar stenosis, systemic corticosteroids, outcome, security
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- cognitive disorder that interferes with the ability to understand or interpret the questionnaires
- Spondylolisthesis except degenerative
- degenerative scoliosis with Cobb angle of 10 °
Sites / Locations
- Santa Marcelina HospitalRecruiting
- Santa Mareclina HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
corticosteroids, analgesics oral pill
placebo
Arm Description
Oral Corticosteroids and oral analgesics
oral placebo and oral analgesics
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01456377
First Posted
October 12, 2011
Last Updated
October 19, 2011
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01456377
Brief Title
The Effectiveness of Oral Corticosteroids in the Treatment of Lumbar Stenosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis of Lumbar Region
Keywords
lumbar stenosis, systemic corticosteroids, outcome, security
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
corticosteroids, analgesics oral pill
Arm Type
Active Comparator
Arm Description
Oral Corticosteroids and oral analgesics
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
oral placebo and oral analgesics
Intervention Type
Drug
Intervention Name(s)
predinose oral
Intervention Description
1 mg for kg for 3 wekees
Intervention Type
Drug
Intervention Name(s)
placebo group
Intervention Description
use a oral placebo
Primary Outcome Measure Information:
Title
effectiveness of oral corticosteroids in the treatment of spinal stenosis
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
effectiveness and security of oral corticosteroids in the treatment of spinal stenosis
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
cognitive disorder that interferes with the ability to understand or interpret the questionnaires
Spondylolisthesis except degenerative
degenerative scoliosis with Cobb angle of 10 °
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luiz Claudio l Rodrigues, doctor
Phone
551120706317
Email
luizclr@terra.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
jamil natour, prof doctor
Phone
551155798087
Email
jnatour@unifesp.br
Facility Information:
Facility Name
Santa Marcelina Hospital
City
São Paulo
State/Province
Sao paulo
ZIP/Postal Code
08270-070
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
edna L Ohana, secretary
Phone
551120706317
Email
ednaohana@ig.com.br
First Name & Middle Initial & Last Name & Degree
Jamil Natour, Doctor
Facility Name
Santa Mareclina Hospital
City
Sao Paulo
ZIP/Postal Code
08270-070
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luiz Claudio L Rodrigues, docctor
Phone
551120706317
Email
luizclr@terra.com.br
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness of Oral Corticosteroids in the Treatment of Lumbar Stenosis
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