The Effectiveness of Oral Corticosteroids in the Treatment of Lumbar Stenosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Luiz Claudio Lacerda Rodrigues, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01456377
First received: October 12, 2011
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

The aim of this study is to evaluate the effectiveness of the use of systemic corticosteroids administered orally in narrow lumbar canal syndrome.


Condition Intervention
Spinal Stenosis of Lumbar Region
Drug: predinose oral
Drug: placebo group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • effectiveness of oral corticosteroids in the treatment of spinal stenosis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 °
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456377

Contacts
Contact: Luiz Claudio l Rodrigues, doctor 551120706317 luizclr@terra.com.br
Contact: jamil natour, prof doctor 551155798087 jnatour@unifesp.br

Locations
Brazil
Santa Marcelina Hospital Recruiting
São Paulo, Sao paulo, Brazil, 08270-070
Contact: edna L Ohana, secretary    551120706317    ednaohana@ig.com.br   
Sub-Investigator: Jamil Natour, Doctor         
Santa Mareclina Hospital Recruiting
Sao Paulo, Brazil, 08270-070
Contact: Luiz Claudio L Rodrigues, docctor    551120706317    luizclr@terra.com.br   
Sponsors and Collaborators
Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Luiz Claudio Lacerda Rodrigues, assisten os spine surgeon group, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01456377     History of Changes
Other Study ID Numbers: 1892/10
Study First Received: October 12, 2011
Last Updated: October 19, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:
lumbar stenosis
systemic corticosteroids
outcome
security

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014