knee osteoarthritis
Conditions
Interventions
This is a four-arm, triple-blind, randomized controlled trial. 132 participants diagnosed with knee osteoarthritis according to the American College of Rheumatology criteria will be recruited. Partici
G11.427.410.698.277
Sponsors
Empresa Brasileira de Serviços Hospitalares
Universidade Federal do Amapá
Hospital Universitário da Universidade Federal do Amapá
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Clinical and radiological diagnosis of knee osteoarthritis according to the American College of Rheumatology criteria. Age 18 years or older. Both sexes. Ability to understand and sign the Informed Consent Form. Presence of knee pain for at least three months impacting functionality. Availability to attend study sessions throughout the intervention period
Exclusion criteria
Exclusion criteria: Previous diagnosis of rheumatoid arthritis, gouty arthritis, infectious arthritis, or other inflammatory joint diseases. History of prior surgery on the affected knee. Use of oral or intra-articular corticosteroids in the last six months. Presence of ulcers, skin infections, or lesions in the intervention application area. Severe neurological or psychiatric diseases that may compromise study participation. Pregnancy or lactation. Use of metallic devices in the knee preventing phonophoresis application. Participation in another clinical trial in the last three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the reduction of inflammatory markers tumor necrosis factor-alpha and interleukins 6 and 1 beta through laboratory tests performed at baseline in the sixth week and at the end of the intervention. ;To evaluate the improvement in pain stiffness and functionality of participants using the Western Ontario and McMaster Universities Osteoarthritis Index applied at baseline in the sixth week and at the end of the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate pain intensity using the Visual Analog Scale at the beginning of the study in the sixth week and at the end of the intervention. ;To assess the quality of life of the participants using the Short Form Health Survey 36 questionnaire applied at the beginning of the study in the sixth week and at the end of the intervention. ;To assess adherence to treatment through a structured questionnaire applied at the end of the intervention. ;Monitor the occurrence of adverse events such as skin reactions, irritation or discomfort in the area of application throughout the study period. | — |
Countries
Brazil
Contacts
Public ContactAlan Cássio Coutinho
Hospital Universitário da Universidade Federal do Amapá
Outcome results
None listed