Knee Osteoarthritis
Conditions
Interventions
This is a randomized, controlled, two-arm clinical trial with a parallel design and a 1:1 allocation ratio. The study is double-blind and includes participants with knee osteoarthritis, who will be ra
Sponsors
Faculdade de Fisioterapia da Universidade Federal de Juiz de Fora
Faculdade de Fisioterapia da Universidade Federal de Juiz de Fora
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants with a diagnosis of knee osteoarthritis according to the clinical criteria of the American College of Rheumatology; aged 18 years or older; no gender restrictions
Exclusion criteria
Exclusion criteria: Secondary knee osteoarthritis (e.g., septic arthritis, inflammatory joint disease, gout, articular fracture, severe dysplasias, congenital abnormalities, or hemochromatosis); systemic arthritic conditions; history of arthroplasty or other surgical interventions in the knee or hip; associated neurological diseases that impair lower limb function (such as post-stroke, neuropathies, or multiple sclerosis); contraindications and precautions related to neuromuscular electrical stimulation, including patients with pacemakers or cardiac defibrillators, deep vein thrombosis, areas with diagnosed or suspected malignancies, active bleeding, infection, skin disease, areas with impaired sensation, or pregnancy; intra-articular corticosteroid injection within the past three month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in pain, assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire administered through an interview, is expected to be observed. For the primary outcome, the score of the pain subscale will be analyzed. A decrease of at least 7.9 points in the pain subscale score compared to baseline will be considered clinically significant, as proposed for patients with knee osteoarthritis. Assessments will be conducted at baseline, immediately after the intervention, and at 12-week follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| An improvement in self-reported physical function, assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire administered through an interview, is expected to be observed. Both the individual subscale scores and the total questionnaire score will be analyzed. A reduction of at least 8–10 points in the total score compared to baseline will be considered clinically significant, as proposed for patients with knee osteoarthritis. Assessments will be conducted at baseline, immediately after the intervention, and at 12-week follow-up;An increase in the maximal voluntary isometric contraction (MVIC) torque of the knee extensors is expected, assessed using a handheld dynamometer (microFET). Torque will be calculated based on the recorded force and the measurement of the lever arm, and values will be normalized to body mass. An increase of at least 25 Nm will be considered a real and clinically meaningful change, as this represents the minimal detectable change (MDC) for quadriceps isometric strength in this population. Assessments will be conducted before and after the intervention, and again at 12 weeks;An improvement is expected in the performance-based physical function tests recommended by the Osteoarthritis Research Society International (OARSI). Clinically meaningful changes will be considered as follows: in the 30-Second Sit-to-Stand Test, an increase of at least 2-3 repetitions; in the 9-Step Stair Climb Test, a reduction of 4,0-5,5 seconds in total time; and in the 40-Meter Fast-Paced Walk Test, an increase in walking speed of 0,2-0,3 m/s or more | — |
Countries
Brazil
Contacts
Public ContactAndressa da Silva
Faculdade de Fisioterapia da Universidade Federal de Juiz de Fora
Outcome results
None listed