Influence of Perception of Patients Suffering of Knee Osteoarthritis Regarding Effectiveness of Intra-articular Injection
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 knee-osteoarthritis
Started Aug 2016
Shorter than P25 for phase_4 knee-osteoarthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2016
CompletedFirst Posted
Study publicly available on registry
July 18, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJuly 18, 2016
July 1, 2016
6 months
July 11, 2016
July 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change on pain
Pain will be evaluated with an visual analogue scale
baseline, after 1, 4 and 12 weeks
Secondary Outcomes (3)
Change on functional capacity
baseline, after 1, 4 and 12 weeks
Change on Catastrophizing
baseline, after 1, 4 and 12 weeks
Change on functional capacity
baseline, after 1, 4 and 12 weeks
Study Arms (2)
Intervention Group
EXPERIMENTALPatients will receive the reception treatment before the joint injection
Control Group
ACTIVE COMPARATORpatient will receive a joint injection
Interventions
joint injection with corticosteroids
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 11, 2016
First Posted
July 18, 2016
Study Start
August 1, 2016
Primary Completion
February 1, 2017
Study Completion
July 1, 2017
Last Updated
July 18, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share