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.

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee; Quadriceps Muscle Atrophy
• Intervention / Treatment: Other: Electrical electrostimulation of the quadriceps muscle (placebo); Other: Electrical electrostimulation of the quadriceps muscle

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Sao Paulo, São Paulo, Brazil, 03156001
      • Recruiting
      • Claudio Cazarini Júnior
      • Contact: Claudio Cazarini; Phone Number: 5511999872295; Email: claudio_cazarini@terra.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Aussie current (placebo) and Exercises	Other: Electrical electrostimulation of the quadriceps muscle (placebo); Exercises associated with electrical electrostimulation (placebo) of the quadriceps muscle of patients with knee osteoarthritis
EXPERIMENTAL: Aussie current and Exercises	Other: Electrical electrostimulation of the quadriceps muscle; Exercises associated with electrical electrostimulation of the quadriceps muscle of patients with knee osteoarthritis

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2020
• Primary Completion (ACTUAL): December 10, 2020
• Study Completion (ANTICIPATED): August 10, 2022

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (ACTUAL): May 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Osteoarthritis; Osteoarthritis, Knee; Muscular Atrophy
• Other Study ID Numbers: Samir Asbahan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No