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

July 13, 2016 updated by: Sandra Regina Toffolo, Federal University of São Paulo

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Patients will receive the reception treatment before the joint injection
joint injection with corticosteroids
Active Comparator: Control Group
patient will receive a joint injection
joint injection with corticosteroids

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 18, 2016

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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