Clinical trial NCT05355922: Efficacy of the Aussie Current in Patients With Knee Osteoarthritis.
Official title: Efficacy of the Aussie Current Associated With Exercise in the Treatment of Patients With Knee Osteoarthritis: a Randomized, Double-blind Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Quadriceps Muscle Atrophy
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Muscle strength
timeFrame: Baseline muscle strength (First day)
measure: Change from Baseline muscle strength at 12 weeks
timeFrame: Change from Baseline muscle strength at 12 weeks
measure: Change from Baseline muscle strength at 24 weeks
timeFrame: Change from Baseline muscle strength at 24 weeks
measure: Pain intensity
timeFrame: baseline pain intensity (First day)
measure: Change from Baseline pain intensity at 12 weeks
timeFrame: Change from Baseline pain intensity at 12 weeks
measure: Change from Baseline pain intensity at 24 weeks
timeFrame: Change from Baseline pain intensity at 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Claudio Cazarini Júnior
state: São Paulo
Study officials:
References:
citation: Cittadin GL, Ansolin GZ, Furtado Santana NP, Tonini TL, Buzanello Azevedo MR, de Albuquerque CE, Flor Bertolini GR. Comparison between Russian and Aussie currents in the grip strength and thickness muscles of the non-dominant hand: A double-blind, prospective, randomized-controlled study. Turk J Phys Med Rehabil. 2020 Nov 9;66(4):423-428. doi: 10.5606/tftrd.2020.4718. eCollection 2020 Dec.
citation: Vaz MA, Frasson VB. Low-Frequency Pulsed Current Versus Kilohertz-Frequency Alternating Current: A Scoping Literature Review. Arch Phys Med Rehabil. 2018 Apr;99(4):792-805. doi: 10.1016/j.apmr.2017.12.001. Epub 2017 Dec 14.