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

F

Federal University of São Paulo

Status and phase

Unknown
Phase 4

Conditions

Knee Osteoarthritis

Treatments

Drug: Joint injection with triamcinolone hexacetonide
Procedure: Reception

Study type

Interventional

Funder types

Other

Identifiers

NCT02835521
CEP UNIFESP - 849746

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Intervention Group
Experimental group
Description:
Patients will receive the reception treatment before the joint injection
Treatment:
Procedure: Reception
Drug: Joint injection with triamcinolone hexacetonide
Control Group
Active Comparator group
Description:
patient will receive a joint injection
Treatment:
Drug: Joint injection with triamcinolone hexacetonide

Trial contacts and locations

0

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Central trial contact

Rita NV Furtado, PhD MD; Sandra R Toffolo, Msc nurse

Data sourced from clinicaltrials.gov

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