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

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: Unknown
• Conditions: Spinal Stenosis of Lumbar Region
• Intervention / Treatment: Drug: predinose oral; Drug: placebo group

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: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luiz Claudio l Rodrigues, doctor; Phone Number: 551120706317; Email: luizclr@terra.com.br
• Study Contact Backup: Name: jamil natour, prof doctor; Phone Number: 551155798087; Email: jnatour@unifesp.br

Study Locations

• Brazil
  • Sao Paulo, Brazil, 08270-070
    • Recruiting
    • Santa Mareclina Hospital
    • Contact: Luiz Claudio L Rodrigues, docctor; Phone Number: 551120706317; Email: luizclr@terra.com.br
  • Sao paulo
    • São Paulo, Sao paulo, Brazil, 08270-070
      • Recruiting
      • Santa Marcelina Hospital
      • Contact: edna L Ohana, secretary; Phone Number: 551120706317; Email: ednaohana@ig.com.br
      • Sub-Investigator: Jamil Natour, Doctor

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): February 1, 2012
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: October 12, 2011
• First Submitted That Met QC Criteria: October 19, 2011
• First Posted (Estimate): October 20, 2011

Study Record Updates

• Last Update Posted (Estimate): October 20, 2011
• Last Update Submitted That Met QC Criteria: October 19, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: outcome; lumbar stenosis; security; systemic corticosteroids
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: 1892/10