Effects of Transcutaneous Electrical Nerve Stimulation (TENS) and Interferential Currents (IFC) on Central Sensitization in Patients With Knee Osteoarthritis: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pressure-pain thresholds
研究概览
简要总结
The aim of this study is to compare the efficacy of transcutaneous electrical nerve stimulation (TENS), interferential currents (IFCs) and sham devices in improving central sensitization (CS) findings, including pressure pain thresholds, pain catastrophizing, depression, and kinesiophobia in patients with knee osteoarthritis (OA).
详细描述
Knee OA, which is the most frequently encountered type of OA is a leading cause of disability and chronic pain. CS is as important as nociceptive component in the pathogenesis of OA-related pain. Therefore, the necessary interventions for CS should be also considered when deciding the treatment protocol.TENS and IFC have been safely and commonly employed in the conservative treatment of knee OA. However, there are limited and inconsistent data concerning the impact of these modalities on CS component of pain.Therefore, the aim of this study is to investigate whether these agents are effective on CS and they are superior to each other.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 to 75 years of age, Having bilateral knee OA radiologically with a Kellgren-Lawrence grade of 2 or
- •Reporting knee pain of more than 3 on the visual analog scale (VAS) over the last 6 months Being unfamiliar with TENS and IFC use
排除标准
- •Having the history of any contraindication for electrotherapy (pacemakers, epilepsy, dermatological conditions, abnormal sensation in the knees, pregnancy),
- •Having a knee surgery or intra-articular corticosteroid or hyaluronic acid injection within 6 months.
- •Taking any drugs acting on the nervous system such as anticonvulsants, antidepressants, myorelaxants, or opioid drugs in the study period.
- •Having fibromyalgia, inflammatory rheumatologic, severe psychological disorders -
结局指标
主要结局
Pressure-pain thresholds
时间窗: Change from baseline pressure-pain thresholds at 2 weeks and at 12 weeks
Pressure pain thresholds is measured on the knee (M. Vastus Medialis) and on the upper part of the homolateral arm (lateral part of M. Deltoideus, 10 cm below acromion) using a pressure algometer. The pressure is raised at a rate of almost 1 kg/s, until the patient first notifies that the pressure sensation changes to a pain sensation.
Tampa Scale of Kinesiophobia
时间窗: Change from baseline kinesiophobia scores at 2 weeks and at 12 weeks
Tampa Scale contains 17 parts that measure anxiety and fear related to movement. The total score ranges between 17-68 points. Higher scores represent higher grades of kinesiophobia.
Beck Depression Inventory (BDI)
时间窗: Change from baseline BDI scores at 2 weeks and at 12 weeks.
Beck Depression Inventory is a 21-item questionnaire that examines the characteristic symptoms of depression.
Pain catastrophizing scale (PCS)
时间窗: Change from baseline PCS scores at 2 weeks and at 12 weeks.
PCS consists of 13 items in three subscales (rumination, helplessness, and magnification). Higher final score indicates more catastrophic thinking related to pain.
次要结局
- Age(Baseline)
- Gender(Baseline)
- Height(Baseline)
- Weight(Baseline)
- Comorbidity(Baseline)
- Visual analogue scale (VAS)(Change from baseline, at 2 weeks and at 12 weeks)
- Western Ontario and McMaster University (WOMAC) Index.(Change from baseline, at 2 weeks and at 12 weeks)
- Timed Up and Go Test (TUG)(Change from baseline, at 2 weeks and at 12 weeks)
- Five Times Sit to Stand Test(Change from baseline, at 2 weeks and at 12 weeks)
研究者
Şahide Eda Almaz
Principal Investigator, MD
Turkish League Against Rheumatism