Does Transcutaneous Electrical Nerve Stimulation (TENS) Affect Pain and Function in Patients With Osteoarthritis of the Knee? ETRELKA, a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- WOMAC pain subscale
研究概览
简要总结
The proposed study is a multi-center, randomized, double blind (patient and assessor), sham controlled clinical trial using a parallel 2 group design recruiting 220 patients of at least 18 years of age. The investigators will include patients presenting with clinically and radiologically diagnosed knee OA according to the criteria of the American College of Rheumatology, who experienced knee pain lasting for at least six months, and were diagnosed with radiographic severity of ≥ 2 on the Kellgren-Lawrence grading system or had one or more of the following signs and symptoms in the knee; restricted range of motion, pain in motion, crepitations, morning stiffness. Patients will be randomly allocated to receive TENS or sham TENS for 3 weeks.
详细描述
Background
Osteoarthritis (OA) is the most common arthritic condition, which is one of the leading causes of disability in adults. Currently, no treatment can stop or reverse the progressive joint degeneration caused by OA. Most clinical interventions aim to improve pain and physical function. Transcutaneous electrical nerve stimulation (TENS) is widely used in the management of knee OA to relieve osteoarthritic pain and facilitate the performance of therapeutic activities in order to maintain or improve physical function. Although its use is widespread, the available evidence is of questionable quality. An adequately sized and well conducted randomized controlled trial (RCT) investigating the effectiveness and safety of TENS as treatment modality for knee OA is warranted to assist clinicians and policy makers to make decisions that are based on high-quality evidence, ultimately optimizing delivery of health-care in knee OA.
Objective
To determine TENS safety and effectiveness on pain and physical function compared to sham TENS in patients with knee OA.
Methods
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women of at least 18 years of age
- •Clinical or radiological diagnosis of knee OA according to the criteria of the American College of Rheumatology
- •Knee pain lasting for six months or longer
- •Radiographic evidence of at least one osteophyte at the tibiofemoral joint (Kellgren-Lawrence grade ≥ 2) or one or more of the following signs and symptoms in the knee; restricted range of motion, pain in motion, crepitations, morning stiffness
- •Written informed consent
- •Exclusion Criteria
- •Patients diagnosed with rheumatoid arthritis or other musculoskeletal diseases affecting lower extremities
- •Relevant effusion in the index knee
- •Known current or remittent cancer
- •Carry cardiac pacemaker or defibrillator in situ
- •Knee surgery in previous 6 months
- •Received treatment with arthrocentesis
- •Intra-articular injection of steroids in previous 3 months
- •Inability to understand instructions or to give informed consent
排除标准
- 未提供
结局指标
主要结局
WOMAC pain subscale
时间窗: End of treatment (at 3 weeks)
次要结局
- Number of drop-outs because of adverse events(End of treatment (at 3 weeks), 3-month follow-up)
- Number of patients experiencing local adverse events(End of treatment (at 3 weeks), 3-month follow-up)
- Overall pain measured on VAS(Baseline, end of treatment (at 3 weeks), 3-month follow-up)
- Number of patients experiencing any side effects(End of treatment (at 3 weeks), 3-month follow-up)
- Number of patients experiencing serious side effects(End of treatment (at 3 weeks), 3-month follow-up)
- WOMAC global subscale(Baseline, end of treatment (at 3 weeks), 3-month follow-up)
- Aberdeen measure of participation(Baseline, end of treatment (at 3 weeks), 3-month follow-up)
- Mean analgesic intake per patient(Baseline, end of treatment (at 3 weeks), 3-month follow-up)
- Number of drop-outs(End of treatment (at 3 weeks), 3-month follow-up)
- WOMAC physical function subscale(Baseline, end of treatment (at 3 weeks), 3-month follow-up)
- Hospital anxiety and depression scale(Baseline, end of treatment (at 3 weeks), 3-month follow-up)
- WOMAC pain subscale(Baseline, third treatment session, 3-month follow-up)