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

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Reception
Joint injection with triamcinolone hexacetonide
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    Patients will receive the reception treatment before the joint injection

    patient will receive a joint injection

    Outcomes

    Primary Outcome Measures

    Change on pain
    Pain will be evaluated with an visual analogue scale

    Secondary Outcome Measures

    Change on functional capacity
    functional capacity will be evaluated with Health assesment questionary (HAQ)
    Change on Catastrophizing
    Catastrophizing will be evaluated with an Catastrophizing test
    Change on functional capacity
    functional capacity will be evaluated with the time to up and go test

    Full Information

    First Posted
    July 11, 2016
    Last Updated
    July 13, 2016
    Sponsor
    Federal University of São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02835521
    Brief Title
    Influence of Perception of Patients Suffering of Knee Osteoarthritis Regarding Effectiveness of Intra-articular Injection
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    February 2017 (Anticipated)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    Patients will receive the reception treatment before the joint injection
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    patient will receive a joint injection
    Intervention Type
    Procedure
    Intervention Name(s)
    Reception
    Intervention Type
    Drug
    Intervention Name(s)
    Joint injection with triamcinolone hexacetonide
    Intervention Description
    joint injection with corticosteroids
    Primary Outcome Measure Information:
    Title
    Change on pain
    Description
    Pain will be evaluated with an visual analogue scale
    Time Frame
    baseline, after 1, 4 and 12 weeks
    Secondary Outcome Measure Information:
    Title
    Change on functional capacity
    Description
    functional capacity will be evaluated with Health assesment questionary (HAQ)
    Time Frame
    baseline, after 1, 4 and 12 weeks
    Title
    Change on Catastrophizing
    Description
    Catastrophizing will be evaluated with an Catastrophizing test
    Time Frame
    baseline, after 1, 4 and 12 weeks
    Title
    Change on functional capacity
    Description
    functional capacity will be evaluated with the time to up and go test
    Time Frame
    baseline, after 1, 4 and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sandra R Toffolo, Msc nurse
    Phone
    551155764239
    Email
    s-regina-toffolo@bol.com.br
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rita NV Furtado, PhD MD
    Phone
    551155764239
    Email
    rvfurtado@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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