Osteoarthritis, KneeNCT05355922
Efficacy of the Aussie Current in Patients With Knee Osteoarthritis.
A study testing Electrical electrostimulation of the quadriceps muscle in people with Osteoarthritis, Knee and Quadriceps Muscle Atrophy, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee, Quadriceps Muscle Atrophy
- What is being tested?
- Electrical electrostimulation of the quadriceps muscle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Feb 2020to 10 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- bearers of severe spine, hip and ankle diseases (fractures and tumors and inflammatory pathologies)
- neurological impairment
- Severe cardiorespiratory diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Claudio Cazarini Júnior
São Paulo, São Paulo, 03156001
Claudio Cazarini, 5511999872295, claudio_cazarini@terra.com.br
About this study
Official title: 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.
- Conditions
- Osteoarthritis, Knee, Quadriceps Muscle Atrophy
- Being tested
- Electrical electrostimulation of the quadriceps muscle, Electrical electrostimulation of the quadriceps muscle (placebo)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical electrostimulation of the quadriceps muscleOther
Exercises associated with electrical electrostimulation of the quadriceps muscle of patients with knee osteoarthritis
Electrical electrostimulation of the quadriceps muscle (placebo)Other
Exercises associated with electrical electrostimulation (placebo) of the quadriceps muscle of patients with knee osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| Aussie current (placebo) and Exercises | Sham comparator | Not described Receives: Other: Electrical electrostimulation of the quadriceps muscle (placebo) |
| Aussie current and Exercises | Experimental | Not described Receives: Other: Electrical electrostimulation of the quadriceps muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Assessment of quadriceps muscle strength with manual dynamometer
Measured: Baseline muscle strength (First day)
Change from Baseline muscle strength at 12 weeks
Assessment of quadriceps muscle strength with manual dynamometer
Measured: Change from Baseline muscle strength at 12 weeks
Change from Baseline muscle strength at 24 weeks
Assessment of quadriceps muscle strength with manual dynamometer
Measured: Change from Baseline muscle strength at 24 weeks
Pain intensity
The numerical pain scale
Measured: baseline pain intensity (First day)
Change from Baseline pain intensity at 12 weeks
The numerical pain scale
Measured: Change from Baseline pain intensity at 12 weeks
Change from Baseline pain intensity at 24 weeks
The numerical pain scale
Measured: Change from Baseline pain intensity at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start10 Feb 2020
- Primary completion10 Dec 2020
- Study completion10 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Cazarini Junior, Faculdade de Ciências Médicas da Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355922
- Sponsor's protocol ID
- Samir Asbahan
- Status last verified
- Feb 2022
- First submitted
- 22 Apr 2021
- Last updated
- 2 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33364562Vaz 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.
PubMed 29247626
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Aussie Current Associated With Exercise in the Treatment of Patients With Knee Osteoarthritis: a Randomized, Double-blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT05355922
- Acronym / sponsor ID
- Samir Asbahan
- Conditions
- Osteoarthritis, Knee, Quadriceps Muscle Atrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Aug 2022 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- bearers of severe spine, hip and ankle diseases (fractures and tumors and inflammatory pathologies)
- neurological impairment
- Severe cardiorespiratory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical electrostimulation of the quadriceps muscleExercises associated with electrical electrostimulation of the quadriceps muscle of patients with knee osteoarthritis | Other | Aussie current and Exercises |
| Electrical electrostimulation of the quadriceps muscle (placebo)Exercises associated with electrical electrostimulation (placebo) of the quadriceps muscle of patients with knee osteoarthritis | Other | Aussie current (placebo) and Exercises |
Primary outcome
Muscle strength
Time frame: Baseline muscle strength (First day)
Assessment of quadriceps muscle strength with manual dynamometer
Change from Baseline muscle strength at 12 weeks
Time frame: Change from Baseline muscle strength at 12 weeks
Assessment of quadriceps muscle strength with manual dynamometer
Change from Baseline muscle strength at 24 weeks
Time frame: Change from Baseline muscle strength at 24 weeks
Assessment of quadriceps muscle strength with manual dynamometer
Pain intensity
Time frame: baseline pain intensity (First day)
The numerical pain scale
Change from Baseline pain intensity at 12 weeks
Time frame: Change from Baseline pain intensity at 12 weeks
The numerical pain scale
Change from Baseline pain intensity at 24 weeks
Time frame: Change from Baseline pain intensity at 24 weeks
The numerical pain scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Background: PubMed 33364562Cittadin 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.
- Background: PubMed 29247626Vaz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical electrostimulation of the quadriceps muscle in people with Osteoarthritis, Knee and Quadriceps Muscle Atrophy, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: Baseline muscle strength (First day)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05355922, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.