- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02835521
Influence of Perception of Patients Suffering of Knee Osteoarthritis Regarding Effectiveness of Intra-articular Injection
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Sandra R Toffolo, Msc nurse
- Phone Number: 551155764239
- Email: s-regina-toffolo@bol.com.br
Study Contact Backup
- Name: Rita NV Furtado, PhD MD
- Phone Number: 551155764239
- Email: rvfurtado@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- CEP UNIFESP - 849746
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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