Efficacy of the Aussie Current in Patients With Knee Osteoarthritis.

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05355922
• Other study ID #: Samir Asbahan
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: August 10, 2022

Study information

• Verified date: February 2022
• Source: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 10, 2022
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscular Atrophy
• Osteoarthritis
• Osteoarthritis, Knee
• Quadriceps Muscle Atrophy

Intervention

Other:
• Electrical electrostimulation of the quadriceps muscle
Exercises associated with electrical electrostimulation of the quadriceps muscle of patients with knee osteoarthritis
• Electrical electrostimulation of the quadriceps muscle (placebo)
Exercises associated with electrical electrostimulation (placebo) of the quadriceps muscle of patients with knee osteoarthritis

Locations

Country	Name	City	State
Brazil	Claudio Cazarini Júnior	Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength	Assessment of quadriceps muscle strength with manual dynamometer	Baseline muscle strength (First day)
Primary	Change from Baseline muscle strength at 12 weeks	Assessment of quadriceps muscle strength with manual dynamometer	Change from Baseline muscle strength at 12 weeks
Primary	Change from Baseline muscle strength at 24 weeks	Assessment of quadriceps muscle strength with manual dynamometer	Change from Baseline muscle strength at 24 weeks
Primary	Pain intensity	The numerical pain scale	baseline pain intensity (First day)
Primary	Change from Baseline pain intensity at 12 weeks	The numerical pain scale	Change from Baseline pain intensity at 12 weeks
Primary	Change from Baseline pain intensity at 24 weeks	The numerical pain scale	Change from Baseline pain intensity at 24 weeks