Neuromuscular Electrical Stimulation (NMES) on Knee Osteoarthritis(OA): an Equivalence Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 主要终点
- Evaluation of the flexibility of the posterior chain muscles
研究概览
简要总结
Objective: To evaluate the effectiveness of neuromuscular electrical stimulation (NMES) combined with closed kinetic chain (CKC) exercises in patients with knee OA.
详细描述
Abstract:
Introduction
Osteoarthritis (OA) is a degenerative and debilitating change that affects the synovial joints.
Objective
To evaluate the effectiveness of neuromuscular electrical stimulation (NMES) combined with closed kinetic chain (CKC) exercises in patients with knee OA.
Methods: Nineteen patients with knee OA were enrolled and randomized into two groups: group I was treated with CKC + NMES, and group II was treated with CKC + NMES placebo. Both groups underwent 20 sessions of mini-squat exercises at 30 degrees of knee flexion that were associated with and interspersed with NMES for 5 minutes at a frequency of 40 hertz (Hz), 10 minutes at 70 Hz and an addition 10 minutes at 150 Hz, for a total of 25 minutes. The data were analyzed using SPSS (Statistical Package for the Social Sciences) version 17.0. Data were expressed as a frequency, mean and standard deviation and were statistically analyzed using a one-way analysis of variance (ANOVA) for repeated measurements followed by Bonferroni's post-hoc test. The investigators also used an unpaired Student's t-test and Kruskal-Wallis and Wilcoxon tests with a level of significance of P < 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with grade I or grade II knee OA (based on the Kellgren-Lawrence classification;
- •which was diagnosed by a medical traumatologist;
- •radiographic changes that demonstrated a reduced joint space in at least one of the compartments of the knee;
- •subchondral bone sclerosis;
- •consent to participate in the study
排除标准
- •patients who had grade III and grade IV knee OA (based on the Kellgren-Lawrence classification);
- •who were involved in another rehabilitation program outside the center;
- •who presented with clinical symptoms that would prevent them from participating in the exercises;
- •who had heart disease;
- •cardiac pacemakers;
- •periarticular metal implants;
- •who experienced changes in sensitivity;
- •who had a previous history of knee injury (meniscus, ligaments, sprains);
- •who had uncontrolled diabetes;
- •neurological disorders with cognitive impairments;
- •rheumatic diseases;
- •history of knee trauma in the last six months;
- •prior knee surgery;
- •three consecutive unexcused absences.
结局指标
主要结局
Evaluation of the flexibility of the posterior chain muscles
时间窗: 6 months
We only observed a significant improvement in the flexibility of the posterior muscle chain for the CKC + NMES group during the initial evaluation compared to the partial evaluation (p=0.012), the partial evaluation compared to the final evaluation (p=0.035) and the initial evaluation compared to the final evaluation (p=0.008). Regarding the scale that was used to classify the level of flexibility, 10% of the subjects in the CKC + NMES group were initially classified as good/excellent. At the end of the protocol, 60% of the subjects were classified as good/excellent (p=0.015)
次要结局
- Evaluation of hamstring and quadriceps muscle strength(6 months)