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
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
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
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
NCT ID
NCT02835521
First Posted
July 11, 2016
Last Updated
July 13, 2016
Sponsor
Federal University of São Paulo
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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