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

NCT ID: NCT02835521

Last Updated: 2016-07-18

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-07-31

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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention Group

Patients will receive the reception treatment before the joint injection

Group Type EXPERIMENTAL

Reception

Intervention Type PROCEDURE

Joint injection with triamcinolone hexacetonide

Intervention Type DRUG

joint injection with corticosteroids

Control Group

patient will receive a joint injection

Group Type ACTIVE_COMPARATOR

Joint injection with triamcinolone hexacetonide

Intervention Type DRUG

joint injection with corticosteroids

Interventions

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Reception

Intervention Type PROCEDURE

Joint injection with triamcinolone hexacetonide

joint injection with corticosteroids

Intervention Type DRUG

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Sandra Regina Toffolo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Sandra R Toffolo, Msc nurse

Role: CONTACT

551155764239

Rita NV Furtado, PhD MD

Role: CONTACT

551155764239

Other Identifiers

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CEP UNIFESP - 849746

Identifier Type: -

Identifier Source: org_study_id

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