Eefficacy of Diadynamic Currents Associated Exercise in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Disability
研究概览
简要总结
Osteoarthritis represents failed repair of joint damage resulting from stresses initiated by any joint or periarticular tissue abnormality. The rate of progression varies among persons and within a knee over time.
The symptoms and signs of knee osteoarthritis include pain, stiffness, reduced joint motion, and muscle weakness. Long-term consequences can include reduced physical activity, deconditioning, impaired sleep, fatigue, depression, and disability.This reduction in activity to avoid pain (kinesiophobia) to evade the onset of pain, especially in the acute phase, limiting their compliance with effective rehabilitation strategies such as regular exercises.
Physical medicine has a wide range of analgesic anti-inflammatory and muscle stimulating treatment methods. Both diadynamic and TENS currents have become the most frequently implemented electrotherapeutic methods. The impact of diadynamic currents consists of analgesic effects and specific dynamics during the formation of physiological processes in tissues.
They occur during the administration of the current and lasts up to a few hours after the treatment has been terminated. One of the theories explaining the analgesic effect of diadynamic currents is the gate control theory of pain by Wall and Melzack. Recently, another theory has become very popular. It explains the analgesic effect provoked by bodies characterized as polypeptides called endorphins. Electric stimulation using diadynamic currents generates an increase in the amount of endorphins in a system.
Although the analgesic impact of TENS therapy is well known, Diadynamic currents therapies have not been studied in knee osteoarthritis pain conditions. Therefore, the aim of the present study was to investigate the medium-term effects of Diadynamic currents combined with exercise on pain and disability in patients with osteoarthritis of the knee.
详细描述
The study included patients who attended the Special Rehabilitation Services in Taboão da Serra-SP, with knee osteoarthritis diagnosed by an independent rehabilitation specialist, and fulfilled the following inclusion criteria: (1) aged from 50 and 75; (2) symptomatic knee osteoarthritis for at least three months; (3) visual analogue scale12 score above 3 and (4) radiographic knee osteoarthritis (uni or bilateral) compatible with Kellgren-Lawrence grade two or higher.
The exclusion criteria were as follows: contraindication to laser application (e.g. cancer and insulin-dependent diabetes); inability to perform the assessment or treatment; continuous use of anti-inflammatory drugs, symptomatic hip osteoarthritis and physiotherapeutic knee treatment within the last 3 months.
All potentially eligible participants were contacted by telephone and those interested in participating were invited to attend a physical examination for inclusion and exclusion criterion. All participants were informed about the study and provided informed consent before participating. They were assigned by block randomization, stratified according to treatment group. An independent researcher not involved in outcome assessment was responsible for group allocation, using a computer-generated random number table. Immediately after baseline assessment by the blinded assessor, the treating physiotherapist accessed the allocation schedule from a centrally located locked cabinet. Patients and the physiotherapist responsible for the evaluation and physiotherapist responsible for the treatment were all unaware of the randomization results as allocation to groups was concealed.
Demographic and anthropometric data, the use of pain relief medications, the duration of knee pain, the knee range of motion, and a range of patient-reported outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.
The primary outcomes were pain intensity measured by the numeric pain rating scale (0-10) with a minimal clinically important change set at two points and disability measured using the Lequesne questionnaire, which consists of 11 questions about pain, discomfort, and function. Scores range from 0 to 24 (from 'no' to 'extremely severe' dysfunction).
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 (Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged from 50 and 75;
- •symptomatic knee osteoarthritis for at least three months;
- •visual analogue scale12 score above 3 and
- •radiographic knee osteoarthritis (uni or bilateral) compatible with Kellgren-Lawrence13 grade two or higher.
排除标准
- •contraindication to laser application (e.g. cancer and insulin-dependent diabetes);
- •inability to perform the assessment or treatment;
- •continuous use of anti-inflammatory drugs,
- •symptomatic hip osteoarthritis
- •physiotherapeutic knee treatment within the last 3 months.
结局指标
主要结局
Change in Disability
时间窗: outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.
Disability measured using the Lequesne questionnaire,14 which consists of 11 questions about pain, discomfort, and function. Scores range from 0 to 24 (from 'no' to 'extremely severe' dysfunction).
Change in pain intensity
时间窗: outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.
Pain intensity measured by the numeric pain rating scale (0-10) with a minimal clinically important change set at two points
次要结局
- Change in Medication intake (Paracetamol) for knee pain relief(outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.)
- Change in Mobility and balance(outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.)
- Change in Range of motion(outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.)
- Change in Physical activity(outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.)
- Change in Muscular strength(outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.)