Effects of TENS During the Performance of a Therapeutic Exercise Protocol in Individuals With Knee Osteoarthritis: Controlled, Randomized, and Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Functional disability
研究概览
简要总结
Research participants diagnosed with knee Osteoarthritis will be randomized through a draw using sealed opaque envelopes indicating two groups: 1. Therapeutic Exercises + Transcutaneous electrical nerve stimulation and 2. Therapeutic Exercises + placebo Transcutaneous electrical nerve stimulation.
Therefore, individuals of both sexes, aged 40 years or over, with a clinical diagnosis of unilateral osteoarthritis of the knee, who present with knee pain for more than three months, morning stiffness for less than 30 minutes, crepitus, bone sensitivity and absence of palpable heat, and diagnosis established radiographically (determined by Kellgren and Lawrence grade 1 to 3 on scale 1 to 4).
Exclusion criteria are bilateral knee Osteoarthritis, hip Osteoarthritis, severe osteoporosis, fibromyalgia, clinical history of tumors or cancer, active inflammatory joint diseases (rheumatoid arthritis, gout), undergoing any lower extremity joint replacement, neurological disorders (Parkinson's disease, stroke, multiple sclerosis, muscular dystrophies, motor neuron disease, Alzheimer's disease), infected wounds or osteomyelitis in the knee region, deep vein thrombosis or thrombophlebitis, sensory changes in the lower limbs, cognitive impairment, and cardiopulmonary disorders that may prevent or limit the execution of exercises, use of a walking assistance device, history of recent trauma to the knee, having undergone any form of treatment involving physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotective within the six months before the start of interventions.
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
- Single (Outcomes Assessor)
盲法说明
Two physiotherapists will be responsible for recruiting and assessing inclusion and exclusion criteria. Therefore, a rheumatologist will be responsible for confirming the OA diagnosis of research participants. A researcher will be responsible for the randomization process. Two physiotherapists, blinded to randomization, will be responsible for the assessment procedures. Two other physiotherapists, one for each group, will apply the interventions.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of unilateral osteoarthritis of the knee
- •presenting knee pain for more than three months
- •morning stiffness for less than 30 minutes
- •crepitus, bone tenderness, and absence of palpable heat.
排除标准
- •Bilateral knee osteoarthritis, hip osteoarthritis
- •severe osteoporosis
- •fibromyalgia
- •medical history of tumors or cancer
- •active inflammatory joint diseases (rheumatoid arthritis, gout),
- •undergoing any lower extremity joint replacement
- •neurological diseases (Parkinson's disease, Accident Cerebral Vascular, Multiple Sclerosis, muscular dystrophies, motor neuron disease, Alzheimer's disease)
- •infected wounds or osteomyelitis in the knee region
- •deep vein thrombosis or thrombophlebitis
- •sensory changes in the lower limbs
- •cognitive and cardiopulmonary impairment that may prevent or limit performing the exercises
- •using a walking assistance device
- •having a history of recent trauma to the knee,
- •having undergone any form of treatment involving physiotherapy
- •intra-articular corticosteroids, anti-inflammatories, or chondroprotective in the six months before the start of the interventions.
结局指标
主要结局
Functional disability
时间窗: Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Knee Injury and Osteoarthritis Outcome Score (KOOS). It aims to evaluate the domains of pain, symptoms, activities of daily living, function related to recreation and sports, and quality of life related to the knee. Totaling 42 items, each item must be answered using a Likert scale that ranges from 0 (best score) to 4 (worst score), and the score for each subscale ranges from 0 (worst score) to 100 (best score).
次要结局
- Numerical Pain Scale(Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.)
- Lower limb functionality(Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.)
- Maximum voluntary isometric contraction(Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.)
- Functionality(Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.)
- Global Perception of Change scale(Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.)
- Self-perceived functionality(Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.)
- Functional self-perception(Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.)
研究者
Cid André Fidelis de Paula Gomes
Principal Investigator
University of Nove de Julho