Efficacy of the Aussie Current in Patients With Knee Osteoarthritis.
Primary Purpose
Osteoarthritis, Knee, Quadriceps Muscle Atrophy
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Electrical electrostimulation of the quadriceps muscle
Electrical electrostimulation of the quadriceps muscle (placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
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
Sites / Locations
- Claudio Cazarini JúniorRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Aussie current (placebo) and Exercises
Aussie current and Exercises
Arm Description
Outcomes
Primary Outcome Measures
Muscle strength
Assessment of quadriceps muscle strength with manual dynamometer
Change from Baseline muscle strength at 12 weeks
Assessment of quadriceps muscle strength with manual dynamometer
Change from Baseline muscle strength at 24 weeks
Assessment of quadriceps muscle strength with manual dynamometer
Pain intensity
The numerical pain scale
Change from Baseline pain intensity at 12 weeks
The numerical pain scale
Change from Baseline pain intensity at 24 weeks
The numerical pain scale
Secondary Outcome Measures
Full Information
NCT ID
NCT05355922
First Posted
April 22, 2021
Last Updated
April 26, 2022
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT05355922
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
August 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Quadriceps Muscle Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aussie current (placebo) and Exercises
Arm Type
Sham Comparator
Arm Title
Aussie current and Exercises
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Electrical electrostimulation of the quadriceps muscle
Intervention Description
Exercises associated with electrical electrostimulation of the quadriceps muscle of patients with knee osteoarthritis
Intervention Type
Other
Intervention Name(s)
Electrical electrostimulation of the quadriceps muscle (placebo)
Intervention Description
Exercises associated with electrical electrostimulation (placebo) of the quadriceps muscle of patients with knee osteoarthritis
Primary Outcome Measure Information:
Title
Muscle strength
Description
Assessment of quadriceps muscle strength with manual dynamometer
Time Frame
Baseline muscle strength (First day)
Title
Change from Baseline muscle strength at 12 weeks
Description
Assessment of quadriceps muscle strength with manual dynamometer
Time Frame
Change from Baseline muscle strength at 12 weeks
Title
Change from Baseline muscle strength at 24 weeks
Description
Assessment of quadriceps muscle strength with manual dynamometer
Time Frame
Change from Baseline muscle strength at 24 weeks
Title
Pain intensity
Description
The numerical pain scale
Time Frame
baseline pain intensity (First day)
Title
Change from Baseline pain intensity at 12 weeks
Description
The numerical pain scale
Time Frame
Change from Baseline pain intensity at 12 weeks
Title
Change from Baseline pain intensity at 24 weeks
Description
The numerical pain scale
Time Frame
Change from Baseline pain intensity at 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Claudio Cazarini Júnior
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
03156001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudio Cazarini
Phone
5511999872295
Email
claudio_cazarini@terra.com.br
12. IPD Sharing Statement
Citations:
PubMed Identifier
33364562
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.
Results Reference
background
PubMed Identifier
29247626
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.
Results Reference
background
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Efficacy of the Aussie Current in Patients With Knee Osteoarthritis.
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