Influence of Perception of Patients Suffering of Knee Osteoarthritis Regarding Effectiveness of Intra-articular Injection

Study Overview
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Brief Summary
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Introduction; reception must be understood as the offered attention within the relationship between a healthcare worker and the patient, including attitudes of inclusion, hearing, valorization of complains and identification of needs, being these individual collective. As a part of this process, communication is a primary and indispensable toll through which the healthcare team and the patient interchange information. Objective: to evaluate the influence of perception of patients suffering of knee osteoarthritis over fear, catastrophizing of pain and effectiveness, related to intra-articular injection od corticosteroids. Material and method: it will be performed a prospective, controlled and randomized study eith a blind evaluator on patients with symptomatic knee osteoarthritis submitted to joint injection. A hundred patients suffering of symptomatic knee osteoarthritis coming from the outpatient area of Rheumatology Division of Federal University of Sao Paulo (UNIFESP) will be evaluated, 50 belonging to the intervention group (reception) and 50 to a control group.

Official Title
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Influence of Perception of Patients Suffering of Osteoarthritis of Knee Over the Effectiveness and Tolerance in Intra-articular Injection of Corticoids: a Prospective, Controlled and Randomized Study

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Reception
* Drug: Joint injection with triamcinolone hexacetonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: knee osteoarthritis according to american college of rheumatology criteria no previous experience of joint injection stable use of drugs for osteoarthritis treatment for at least 3 months stable dose of corticosteroids, non hormonal anti-inflammatory and analgesics in the previous month pain on knee between 3 and 7 in the visual analogue scale signe the informed consent term radiologic classification between 1-3 (kellgren and Lawrence classification) Exclusion Criteria: joint disease of different etiology coagulation alteration non treated fibromyalgia litigation diabetes mellitus and systemic arterial hypertension out of control allergy of lidocaine or triamcinolone hexacetonide

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Patients will receive the reception treatment before the joint injection | Procedure: Reception<br> <br> Drug: Joint injection with triamcinolone hexacetonide<br>* joint injection with corticosteroids<br>|
| Active Comparator: Control Group<br>patient will receive a joint injection | Drug: Joint injection with triamcinolone hexacetonide<br>* joint injection with corticosteroids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on pain | Pain will be evaluated with an visual analogue scale | baseline, after 1, 4 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on functional capacity | functional capacity will be evaluated with Health assesment questionary (HAQ) | baseline, after 1, 4 and 12 weeks | 
| Change on Catastrophizing | Catastrophizing will be evaluated with an Catastrophizing test | baseline, after 1, 4 and 12 weeks | 
| Change on functional capacity | functional capacity will be evaluated with the time to up and go test | baseline, after 1, 4 and 12 weeks |