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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02835521
• Other study ID #: CEP UNIFESP - 849746
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 11, 2016
• Last updated: July 13, 2016
• Start date: August 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2016
• Source: Federal University of São Paulo
• Contact: Sandra R Toffolo, Msc nurse
• Phone: 551155764239
• Email: s-regina-toffolo[@]bol.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Reception

Drug:
• Joint injection with triamcinolone hexacetonide
joint injection with corticosteroids

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on pain	Pain will be evaluated with an visual analogue scale	baseline, after 1, 4 and 12 weeks	No
Secondary	Change on functional capacity	functional capacity will be evaluated with Health assesment questionary (HAQ)	baseline, after 1, 4 and 12 weeks	No
Secondary	Change on Catastrophizing	Catastrophizing will be evaluated with an Catastrophizing test	baseline, after 1, 4 and 12 weeks	No
Secondary	Change on functional capacity	functional capacity will be evaluated with the time to up and go test	baseline, after 1, 4 and 12 weeks	No