Effectiveness of Facet Joint Infiltration in Low Back Pain

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of facet joint infiltration with corticosteroids in the treatment of low back pain due to facet joint osteoarthritis.

Detailed Description
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Sixty subjects with diagnostic of facet joint syndrome will be enrolled in the study. 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).

Official Title
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Effectiveness of Facet Joint Infiltration in Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Cortisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: low back pain up to 3 months pain on back extension radiologic findings of facet joint osteoarthritis Exclusion Criteria: other causes of back pain fibromyalgia diabetes, arterial hypertension or glaucoma not well controlled patients with contrast allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: facet joint infiltration<br>The experimental group will be submitted to intra-articular infiltration of six facet joints (L3/L4;L4/L5;L5/S1 bilaterally) with triamcinolone hexacetonide | Drug: Cortisone<br>* intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide<br>|
| Active Comparator: intramuscular injection<br>The control group which were submitted to triamcinolone acetonide intramuscular injection of six lumbar paravertebral points | Drug: Cortisone<br>* intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain visual analogic scale | pain visual scale graduated from zero to ten | baseline | 
| pain visual analogic scale | pain visual analogic scale graduated 0--10 | 4 weeks | 
| pain visual analogic scale | pain visual analogic scale graduated 0--10 | 12 weeks | 
| pain visual analogic scale | pain visual analogic scale graduated 0--10 | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rolland Morris questionnaire | assess functional capacity | baseline | 
| Rolland Morris questionnaire | assess functional capacity | 4 weeks | 
| Rolland Morris questionnaire | assess functional capacity | 12 weeks | 
| Rolland Morris questionnaire | assess functional capacity | 24 weeks | 
| SF-36 questionnaire | assess quality of life | baseline | 
| SF-36 questionnaire | assess quality of life | 4 weeks | 
| SF-36 questionnaire | assess quality of life | 12 weeks | 
| SF-36 questionnaire | assess quality of life | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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facet joint, back pain, osteoarthritis, infiltration