Effectiveness of Facet Joint Infiltration in Low Back Pain
NCT ID: NCT01447160
Last Updated: 2011-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2011-10-31
2012-04-30
Brief Summary
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Detailed Description
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They were randomized into experimental and control groups. The experimental group will be submitted to intra-articular infiltration of six facet joints. The control group will be submitted to intramuscular injection of six lumbar paravertebral points. After the randomization, all subjects will be assessed by an investigator blinded to the groups. The assessment will be taken just before the interventions (T0) and them 7 , 30 , 90 and 180 days after the interventions. The following assessment instruments will be used: pain visual analogical scale (VAS) (0-10cm), pain visual analogical scale during extension of the spine (VAS E) (0-10cm), Likert scale for improving (0-5), percentage scale of subjective improving perception(0-100%), Rolland-Morris questionnaire (0-24), short health survey questionnaire (SF36), accountability of medications taken for back pain: analgesics and non-steroidal antiinflammatories (NSAIDs).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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facet joint infiltration
The experimental group will be submitted to intra-articular infiltration of six facet joints (L3/L4;L4/L5;L5/S1 bilaterally) with triamcinolone hexacetonide
Cortisone
intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide
intramuscular injection
The control group which were submitted to triamcinolone acetonide intramuscular injection of six lumbar paravertebral points
Cortisone
intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide
Interventions
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Cortisone
intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide
Eligibility Criteria
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Inclusion Criteria
* pain on back extension
* radiologic findings of facet joint osteoarthritis
Exclusion Criteria
* fibromyalgia
* diabetes, arterial hypertension or glaucoma not well controlled
* patients with contrast allergy
18 Years
80 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Federal University of São Paulo
Principal Investigators
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Luiza Ribeiro, doctor
Role: PRINCIPAL_INVESTIGATOR
Sao Paulo Federal University
Locations
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Sao Paulo federal University
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Other Identifiers
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FUSao Paulo
Identifier Type: -
Identifier Source: org_study_id