Efficacy of the Aussie Current in Patients With Knee Osteoarthritis.

Study Overview
=================
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.

Official Title
-----------------
Efficacy of the Aussie Current Associated With Exercise in the Treatment of Patients With Knee Osteoarthritis: a Randomized, Double-blind Clinical Trial.

Conditions
-----------------
Osteoarthritis, Knee, Quadriceps Muscle Atrophy

Intervention / Treatment
-----------------
* Other: Electrical electrostimulation of the quadriceps muscle
* Other: Electrical electrostimulation of the quadriceps muscle (placebo)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Aussie current (placebo) and Exercises<br> | Other: Electrical electrostimulation of the quadriceps muscle (placebo)<br>* Exercises associated with electrical electrostimulation (placebo) of the quadriceps muscle of patients with knee osteoarthritis<br>|
| Experimental: Aussie current and Exercises<br> | Other: Electrical electrostimulation of the quadriceps muscle<br>* Exercises associated with electrical electrostimulation of the quadriceps muscle of patients with knee osteoarthritis<br>|

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 |