Efficacy of Percutaneous Electrical Stimulation Compared to Transcutaneous Electrical Stimulation in Combination With an Education and Exercise Program in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from baseline to immediately after the first session in VAS
研究概览
简要总结
The purpose of this study is to compare the effectiveness of percutaneous electrotherapy treatment with transcutaneous and placebo.
详细描述
There is evidence of the benefit of therapeutic exercise on pain intensity and functionality in patients with osteoarthritis of the knee. However, there is a lack of evidence of its effectiveness when applied in combination with new treatment strategies such as percutaneous electrostimulation and therapeutic pain education.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 45 years
- •Have activity related joint pain
- •Have morning stiffness ≤30 min
- •Knee pain of at least 6 months duration
- •OA diagnosis by physician
- •Current levels of moderate/vigorous physical activity (MVPA) below physical activity guideline recommendations (< 150 min/week of MVPA; assessed using the Active Australia Physical Activity Questionnaire)
排除标准
- •Health conditions that prevent safe participation in physical activity interventions as listed in the American College of Sports Medicine Guidelines (e.g., cardiac or lung disease).
- •Pain in other body areas that currently limits walking ability (e.g., back pain, foot pain, hip pain)
- •Neurological disorders affecting lower limb movement (e.g., multiple sclerosis or stroke).
- •Inflammatory arthritis (including rheumatoid arthritis)
- •Fibromyalgia
- •Previously operated knee is the most painful knee
- •Any condition impacting decision-making/memory (e.g., Alzheimer's, dementia)
- •Severe depression
- •Current moderate/vigorous physical activity levels above guideline recommendations (≥150 min/week; assessed using the Active Australia Physical Activity Questionnaire)
- •Currently undergoing regular, active intervention for the knee (e.g., seeing a physiotherapist)
- •Unable to commit to study requirements (unable to attend study appointments or complete study outcomes)
结局指标
主要结局
Change from baseline to immediately after the first session in VAS
时间窗: At baseline and immediately after the first session
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Change from baseline to one month in WOMAC
时间窗: At baseline and at one month
The Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.
Change from baseline to three months in WOMAC
时间窗: At baseline and at three months
The Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.
Change from baseline to three months in VAS
时间窗: At baseline and at three months
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Change from baseline to six months in WOMAC
时间窗: At baseline and at six months
The Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.
Change from baseline to one month in VAS
时间窗: At baseline and at one month
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Change from baseline to six months in VAS
时间窗: At baseline and at six months
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
次要结局
- Change from baseline to three months in PPT(At baseline and at three months)
- Change from baseline to immediately after the first session in CPM(At baseline and immediately after the first session)
- Change from baseline to one month in PPT(At baseline and at one month)
- Change from baseline to six months in PPT(At baseline and at six months)
- Change from baseline to three months in CPM(At baseline and at three months)
- Change from baseline to immediately after the first session in TSP(At baseline and immediately after the first session)
- Change from baseline to three months in GCPS(At baseline and at three months)
- Change from baseline to immediately after the first session in PPT(At baseline and immediately after the first session)
- Change from baseline to six months in CPM(At baseline and at six months)
- Change from baseline to three months in TSP(At baseline and at three months)
- Change from baseline to six months in TUG(At baseline and at six months)
- Baseline Mini-Mental Status(At baseline)
- Change from baseline to six months in STAI(At baseline and at six months)
- Change from baseline to three months in PCS(At baseline and at three months)
- Change from baseline to one month in TSP(At baseline and at one month)
- Change from baseline to six months in GCPS(At baseline and at six months)
- Change from baseline to one month in CPM(At baseline and at one month)
- Change from baseline to one month in TUG(At baseline and at one month)
- Change from baseline to three months in TUG(At baseline and at three months)
- Change from baseline to one month in BDI-II(At baseline and at one month)
- Change from baseline to immediately after the first intervention in catastrophism in vivo(At baseline and immediately after the first intervention)
- Change from baseline to one month in GROC(At baseline and at one month)
- Change from baseline to three months in GROC(At baseline and at three months)
- Change from baseline to six months in SPPB(At baseline and at six months)
- Change from baseline to six months in TSP(At baseline and at six months)
- Change from baseline to one month in GCPS(At baseline and at one month)
- Change from baseline to three months in STAI(At baseline and at three months)
- Change from baseline to six months in PCS(At baseline and at six months)
- Change from baseline to six months in CRES-4(At baseline and at six months)
- Change from baseline to six months in GROC(At baseline and at six months)
- Change from baseline to one month in STAI(At baseline and at one month)
- Change from baseline to six months in BDI-II(At baseline and at six months)
- Change from baseline to one month in PCS(At baseline and at one month)
- Change from baseline to three months in TSK-11(At baseline and at three months)
- Change from baseline to one month in CRES-4(At baseline and at one month)
- Change from baseline to three months in CRES-4(At baseline and at three months)
- Change from baseline to one month in SF-12(At baseline and at one month)
- Change from baseline to three months in BDI-II(At baseline and at three months)
- Change from baseline to one month in TSK-11(At baseline and at one month)
- Change from baseline to six months in TSK-11(At baseline and at six months)
- Baseline Demographic and Clinical Characteristics(At baseline)
- Change from baseline to one month in SPPB(At baseline and at one month)
- Change from baseline to three months in SPPB(At baseline and at three months)
- Change from baseline to six months in SF-12(At baseline and at six months)
- Change from baseline to three months in SF-12(At baseline and at three months)
研究者
Josue Fernandez Carnero
Professor
Universidad Rey Juan Carlos