Osteo Arthritis Knee Clinical Trial
Official title:
Assessment of Short-term Effectiveness of Five Local Treatment Modalities in Patients With Symptomatic Knee Osteoarthritis: a Randomized Prospective Study
BACKGROUND: Current medical treatment strategies for knee osteoarthritis (OA) are aimed at
pain reduction and symptom control. The Non-Arthroscopic Joint Lavage (NAJL) is included
inside the therapeutic algorithm of knee OA when other therapies are contraindicated or have
lost effectiveness. The large variety of potentially invasive interventions available (joint
lavage included) has raised the need to assess their efficacy. The objective of this study is
to compare the short-term effectiveness of five treatment strategies in patients with knee
osteoarthritis (OA).
METHODS: It was conducted a randomized prospective study involving 150 patients of whom 76.7%
were females. The age range was 40-81 years. All patients had knee OA according to the
American College of Rheumatology criteria, with Kellgren-Lawrence radiographic grades II and
III. Patients were assigned to five groups, 1) non-arthroscopic joint lavage (NAJL) (n= 30),
2) NAJL plus hyaluronic acid (HA) (n= 32), 3) NAJL plus corticosteroid (CS) (n= 32), 4) HA
(n= 31), 5) CS (n= 25). Evaluations took place at baseline, one and three months after
enrollment. Demographic variables, Western Ontario and McMaster University Osteoarthritis
Index (WOMAC) and Lequesne scores were recorded. Statistical analysis included mixed analysis
of variance, post-hoc comparisons with Sidak's adjustment, and multiple linear regression
using as outcome WOMAC total at 3 months.
TRIAL REGISTRATION: The protocol of the study was approved by the "Hospital Universitario
Reina Sofía" Ethics Committee, under the number 1996, in the Minutes 208 of 29 May 2012.
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