Effects of Transcranial Direct Current Stimulation (tDCS) on Knee Osteoarthritis Pain in Elderly Subjects With Defective Endogenous Pain-Inhibitory System: Protocol for a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Changes in Pain Scale
研究概览
简要总结
The purpose of this study is to evaluate if anodal tDCS stimulation over M1 may decrease chronic knee OA pain in elderly subjects with defective CPM. In addition, this trial will help to investigate the role of central sensitization in knee OA and evaluate how tDCS stimulation may affect it.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals > 60 years old, of both genders.
- •Diagnosis of primary knee osteoarthritis with chronic pain self-reported.
- •Be able to sign the informed consent to participate in the study.
- •Chronic pain (over the past 6 months) of at least 4 on a 0-10 VAS scale on average.
- •Reduction on VAS (visual analogic scale) during CPM (conditioned pain modulation) < 10%
排除标准
- •Contraindications to transcranial brain stimulation, i.e. implanted brain medical devices or implanted brain metallic devices.
- •Severe acute or chronic decompensated disease.
- •Cognitive and behavioral impairment.
- •Epilepsy.
- •History of fractures in the lower limbs and/or spine in the last 6 months.
- •Use of carbamazepine within the past 6 months as self-reported.
- •Severe depression (with a score of >30 in the Beck Depression Inventory)
- •History of syncope.
- •Traumatic brain injury with residual neurological deficits.
- •History of alcohol abuse within the past 6 months as self-reported.
研究组 & 干预措施
Active tDCS
Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.
干预措施: Active Transcranial Direct Current Stimulation (tDCS) (Device)
Sham tDCS
Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.
干预措施: Sham Transcranial Direct Current Stimulation (tDCS) (Device)
结局指标
主要结局
Changes in Pain Scale
时间窗: Measured at baseline and up to 60 days after the end of stimulation
Determine whether anodal transcranial direct current stimulation is effective in reducing pain in subjects with chronic pain due to knee osteoarthritis, as measured by changes in the Brief Pain Inventory (BPI)
次要结局
- Changes in Quality of Life(Measured at baseline, 15, 30 and 60 days after the of stimulation)
- Changes in Physical Function as measured through Lequesne Index(Measured at baseline, 15, 30, and 60 days after the end of stimulation)
- Changes in Patient Global Assessment(Measured at baseline, 15, 30 and 60 after the end of stimulation)
- Changes in Physical Function as measured through Western Ontário and McMaster Universities Osteoarthritis Index(Measured at baseline, 15, 30 and 60 days after the end of stimulation)
- Adverse Events(Up to 60 days after the end of stimulation)
- Changes in Mood(Up to 60 days after the end of stimulation)
- Changes in cognition(Up to 60 days after the end of stimulation)
- One leg standing balance test(Measured at baseline, 15, 30 and 60 days after the end of stimulation)
- Timed Up and Go Test(Measured at baseline, 15, 30 and 60 days after the end of stimulation)
- Changes Pain Pressure Threshold (PPT)(Measured at baseline, 15, 30 and 60 days after the end of stimulation)
- Changes in mechanical detection threshold as measured through Von-Frey monofilaments(Measured at baseline, 15, 30 and 60 days after the end of stimulation)
- Changes in mechanical pain threshold as measured through Von-Frey monofilaments(Measured at baseline, 15, 30 and 60 days after the end of stimulation)
- Descending Noxious Inhibitory Control (DNIC)(Measured at baseline, 15, 30 and 60 days after the end of stimulation)
研究者
Daniela Regina Brandão Tavares
Geriatrician
Federal University of São Paulo