The Effectiveness of Oral Corticosteroids in the Treatment of Lumbar Stenosis
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
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 12, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedOctober 20, 2011
October 1, 2011
7 months
October 12, 2011
October 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
3 months
Secondary Outcomes (1)
effectiveness and security of oral corticosteroids in the treatment of spinal stenosis
3 months
Study Arms (2)
corticosteroids, analgesics oral pill
ACTIVE COMPARATOROral Corticosteroids and oral analgesics
placebo
PLACEBO COMPARATORoral placebo and oral analgesics
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 °
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Santa Marcelina Hospital
São Paulo, São Paulo, 08270-070, Brazil
Santa Mareclina Hospital
São Paulo, São Paulo, 08270-070, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assisten os spine surgeon group
Study Record Dates
First Submitted
October 12, 2011
First Posted
October 20, 2011
Study Start
July 1, 2011
Primary Completion
February 1, 2012
Study Completion
June 1, 2012
Last Updated
October 20, 2011
Record last verified: 2011-10