Efficacy of the Aussie Current Associated With Exercise in the Treatment of Patients With Knee Osteoarthritis: a Randomized, Double-blind Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline muscle strength at 24 weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •bearers of severe spine, hip and ankle diseases (fractures and tumors and inflammatory pathologies)
- •neurological impairment
- •Severe cardiorespiratory diseases
研究组 & 干预措施
Aussie current and Exercises
干预措施: Electrical electrostimulation of the quadriceps muscle (Other)
Aussie current (placebo) and Exercises
干预措施: Electrical electrostimulation of the quadriceps muscle (placebo) (Other)
结局指标
主要结局
Change from Baseline muscle strength at 24 weeks
时间窗: Change from Baseline muscle strength at 24 weeks
Assessment of quadriceps muscle strength with manual dynamometer
Pain intensity
时间窗: baseline pain intensity (First day)
The numerical pain scale
Change from Baseline pain intensity at 12 weeks
时间窗: Change from Baseline pain intensity at 12 weeks
The numerical pain scale
Change from Baseline pain intensity at 24 weeks
时间窗: Change from Baseline pain intensity at 24 weeks
The numerical pain scale
Muscle strength
时间窗: Baseline muscle strength (First day)
Assessment of quadriceps muscle strength with manual dynamometer
Change from Baseline muscle strength at 12 weeks
时间窗: Change from Baseline muscle strength at 12 weeks
Assessment of quadriceps muscle strength with manual dynamometer
次要结局
未报告次要终点
研究者
Claudio Cazarini Junior
Doctor of Health Sciences
Faculdade de Ciências Médicas da Santa Casa de São Paulo