Clinical trial NCT01456377: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Stenosis of Lumbar Region
Keywords: lumbar stenosis
systemic corticosteroids
outcome
security
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-10-20
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 °

Primary outcomes:
measure: effectiveness of oral corticosteroids in the treatment of spinal stenosis
timeFrame: 3 months
Secondary outcomes:
measure: effectiveness and security of oral corticosteroids in the treatment of spinal stenosis
timeFrame: 3 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Santa Marcelina Hospital
state: Sao paulo
city: Sao Paulo
country: Brazil
facility: Santa Mareclina Hospital
Study officials:
References: