Unilateral primary osteoarthritis of knee
Conditions
Interventions
This is a randomized controlled two-arm clinical trial, double-blind, and an interventional and prospective study conducted at the Orthopedics and Traumatology Service of the Armed Forces Hospital (HF
Sponsors
Universidade Católica de Brasília - UCB
Hospital das Forças Armadas - HFA
Eligibility
Age
60 Years to 79 Years
Inclusion criteria
Inclusion criteria: Both sexes; aged between 60 and 79 years; diagnosed with KOA confirmed by radiographic evidence, according to Ahlbäck's radiological classification on X-ray; being able to understand the study and voluntarily agree to participate, being accompanied by family members and after comprehension is observed by the interviewer; having no restrictions regarding the use of TOCE
Exclusion criteria
Exclusion criteria: Previous treatment with TOCE or any other treatment for knee osteoarthritis in the last six months; active infection in the knee joint; having undergone viscosupplementation in the knee less than a year ago; meeting at least one of the following contraindications: use of a pacemaker; diagnosis of deep vein thrombosis (DVT); diagnosis of cancer at any stage; patient having a blood coagulation abnormality (coagulopathy), or taking any type of anticoagulant; primary malignant disease (tumors) in the treatment area; acute soft tissue or bone infection; systemic infections; epilepsy; corticosteroid infiltration at the application site in the last 6 weeks; patient at high risk from any type of anesthesia or analgesia if it eventually needs to be used
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The expected primary outcome 1 will be pain reduction, assessed by the Visual Analog Scale (VAS), before the start (T0), at the end (T1), and one month after the end of the therapeutic plan (T2);The outcome found 1 was that the GI Group started the study in worse clinical condition. The TOCE intervention resulted in faster improvement in pain relief. At the end of 30 days, both groups reached similar levels of functional and symptomatic improvement, suggesting comparable efficacy in the medium term | — |
Secondary
| Measure | Time frame |
|---|---|
| The expected secondary outcomes 2 will be improvement in function, assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Index) at T0, T1, and T2, as well as the occurrence of adverse effects;The outcome found 2 was that, after 30 days, both groups reached similar levels of functional and symptomatic improvement, suggesting comparable efficacy in the medium term. There were no reports of side effects in either group | — |
Countries
Brazil
Contacts
Public ContactMario Zambon
Hospital das Forças Armadas - HFA
Outcome results
None listed