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

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ClinicalTrials.gov Identifier: NCT02835521
Recruitment Status : Unknown
Verified July 2016 by Sandra Regina Toffolo, Federal University of São Paulo.
Recruitment status was:  Not yet recruiting
First Posted : July 18, 2016
Last Update Posted : July 18, 2016
Sponsor:
Information provided by (Responsible Party):
Sandra Regina Toffolo, Federal University of São Paulo

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.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: Reception Drug: Joint injection with triamcinolone hexacetonide Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : August 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Intervention Group
Patients will receive the reception treatment before the joint injection
Procedure: Reception
Drug: Joint injection with triamcinolone hexacetonide
joint injection with corticosteroids

Active Comparator: Control Group
patient will receive a joint injection
Drug: Joint injection with triamcinolone hexacetonide
joint injection with corticosteroids




Primary Outcome Measures :
  1. Change on pain [ Time Frame: baseline, after 1, 4 and 12 weeks ]
    Pain will be evaluated with an visual analogue scale


Secondary Outcome Measures :
  1. Change on functional capacity [ Time Frame: baseline, after 1, 4 and 12 weeks ]
    functional capacity will be evaluated with Health assesment questionary (HAQ)

  2. Change on Catastrophizing [ Time Frame: baseline, after 1, 4 and 12 weeks ]
    Catastrophizing will be evaluated with an Catastrophizing test

  3. 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



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835521


Contacts
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Contact: Sandra R Toffolo, Msc nurse 551155764239 s-regina-toffolo@bol.com.br
Contact: Rita NV Furtado, PhD MD 551155764239 rvfurtado@hotmail.com

Sponsors and Collaborators
Federal University of São Paulo

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Responsible Party: Sandra Regina Toffolo, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02835521     History of Changes
Other Study ID Numbers: CEP UNIFESP - 849746
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action