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Efficacy of the Aussie Current in Patients With Knee Osteoarthritis.

Efficacy of the Aussie Current Associated With Exercise in the Treatment of Patients With Knee Osteoarthritis: a Randomized, Double-blind Clinical Trial.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05355922
Enrollment
40
Registered
2022-05-02
Start date
2020-02-10
Completion date
2022-08-10
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee, Quadriceps Muscle Atrophy

Brief summary

Introduction: Osteoarthritis (OA) of the knee is a musculoskeletal disorder and is associated with significant implications related to public health and socioeconomic factors resulting in leave from work. Currently, there are several types of conservative treatment for this pathology, such as medications and mainly muscle strengthening, recommended by international guidelines. It can be associated with neuromuscular electrostimulation (NMES) as with the Aussie Current, for example, which aims to increase strength and function earlier. Objective: To determine whether the effectiveness of adding NMES to the Aussie Current in patients with knee OA who receive treatment based on the principles of conventional physiotherapy, in relation to pain relief, improvement of functional disability and muscle strength. Materials and Method: Forty individuals will be randomly distributed in two groups, with group 1 (G1) exercises and placebo application of electrostimulation and group 2 (G2) exercises and application of NMES with the Aussie current in the quadriceps femoris muscle. In the treatment, 24 sessions will be carried out in a period of 12 weeks based on the gold standard for the treatment of knee OA. Clinical outcomes of pain intensity, functional disability and muscle strength will be measured at baseline, immediately after 12-week treatment and after 24-week follow-up by a single blinded evaluator at all stages. All statistical procedures will be carried out following the principles of intention to treat and the comparison between groups will be carried out through the test of Mixed Linear Models. Expected Results: It is expected that there will be improvement in the variables: pain, functional capacity and strength in both the groups, however in the group that carried out the application of the Aussie Current, the gains would be more precocious, when compared to the group that did not carry out the NMES.

Interventions

OTHERElectrical electrostimulation of the quadriceps muscle

Exercises associated with electrical electrostimulation of the quadriceps muscle of patients with knee osteoarthritis

OTHERElectrical electrostimulation of the quadriceps muscle (placebo)

Exercises associated with electrical electrostimulation (placebo) of the quadriceps muscle of patients with knee osteoarthritis

Sponsors

Faculdade de Ciências Médicas da Santa Casa de São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* medical diagnosis of OA in the knees, * pain for another 06 months * both genders * age between 45 and 80 years * Grade I to III, according to Kellgren-Lawrence.

Exclusion criteria

* bearers of severe spine, hip and ankle diseases (fractures and tumors and inflammatory pathologies) * neurological impairment * Severe cardiorespiratory diseases

Design outcomes

Primary

MeasureTime frameDescription
Muscle strengthBaseline muscle strength (First day)Assessment of quadriceps muscle strength with manual dynamometer
Change from Baseline muscle strength at 12 weeksChange from Baseline muscle strength at 12 weeksAssessment of quadriceps muscle strength with manual dynamometer
Change from Baseline muscle strength at 24 weeksChange from Baseline muscle strength at 24 weeksAssessment of quadriceps muscle strength with manual dynamometer
Pain intensitybaseline pain intensity (First day)The numerical pain scale
Change from Baseline pain intensity at 12 weeksChange from Baseline pain intensity at 12 weeksThe numerical pain scale
Change from Baseline pain intensity at 24 weeksChange from Baseline pain intensity at 24 weeksThe numerical pain scale

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026