The Effectiveness of Oral Corticosteroids in the Treatment of Lumbar Stenosis

October 19, 2011 updated by: Luiz Claudio Lacerda Rodrigues, Federal University of São Paulo

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 08270-070
        • Recruiting
        • Santa Mareclina Hospital
        • Contact:
    • Sao paulo
      • São Paulo, Sao paulo, Brazil, 08270-070
        • Recruiting
        • Santa Marcelina Hospital
        • Contact:
        • Sub-Investigator:
          • Jamil Natour, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 °

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: corticosteroids, analgesics oral pill
Oral Corticosteroids and oral analgesics
Drug: predinose oral
1 mg for kg for 3 wekees
Placebo Comparator: placebo
oral placebo and oral analgesics
Drug: placebo group
use a oral placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
effectiveness and security of oral corticosteroids in the treatment of spinal stenosis
Time Frame: 3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1892/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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