Efficacy of the Aussie Current in Patients With Knee Osteoarthritis.

NCT05355922 | Unknown

• 1 other identifier: Samir Asbahan
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Quadriceps Muscle Atrophy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Aussie current (placebo) and Exercises

SHAM COMPARATOR

Other: Electrical electrostimulation of the quadriceps muscle (placebo)

Aussie current and Exercises

EXPERIMENTAL

Other: Electrical electrostimulation of the quadriceps muscle

Interventions

Electrical electrostimulation of the quadriceps muscle OTHER

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

Aussie current and Exercises

Electrical electrostimulation of the quadriceps muscle (placebo) OTHER

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

Aussie current (placebo) and Exercises

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Claudio Cazarini Júnior

São Paulo, São Paulo, 03156001, Brazil

RECRUITING

Related 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.

  PMID: 33364562 BACKGROUND

• 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.

  PMID: 29247626 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Health Sciences

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 2, 2022
• Study Start: February 10, 2020
• Primary Completion: December 10, 2020
• Study Completion: August 10, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-02

Locations

BR (1)