Efficacy of the Aussie Current in Patients With Knee Osteoarthritis.

NCT ID: NCT05355922

Last Updated: 2022-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2022-08-10

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee Quadriceps Muscle Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aussie current (placebo) and Exercises

Group Type SHAM_COMPARATOR

Electrical electrostimulation of the quadriceps muscle (placebo)

Intervention Type OTHER

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

Aussie current and Exercises

Group Type EXPERIMENTAL

Electrical electrostimulation of the quadriceps muscle

Intervention Type OTHER

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

Interventions

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Electrical electrostimulation of the quadriceps muscle

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

Intervention Type OTHER

Electrical electrostimulation of the quadriceps muscle (placebo)

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculdade de Ciências Médicas da Santa Casa de São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Claudio Cazarini Junior

Doctor of Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Claudio Cazarini Júnior

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Claudio Cazarini

Role: primary

5511999872295

References

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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.

Reference Type BACKGROUND
PMID: 33364562 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29247626 (View on PubMed)

Other Identifiers

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Samir Asbahan

Identifier Type: -

Identifier Source: org_study_id

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