Effects of Transcranial Direct Current Stimulation (tDCS) and Exercise Versus Sham tDCS and Exercise on Pain Control in Chronic Painful Total Knee Arthroplasty (TKA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change of neuropathic pain presence
研究概览
简要总结
The TSEF-PTG study aims to evaluate the effects of transcranial Direct Current Stimulation (tDCS) and exercise versus sham tDCS (placebo) and exercise on pain control in chronic painful total knee arthroplasty (TKA) patients.
详细描述
The TSEF-PTG study is a single center, double blinded randomized controlled trial.
The aim is to evaluate the effects of a tDCS stimulation and exercise vs sham tDCS and exercise on pain control in chronic (lasting more than 3 months from the intervention) painful total knee arthroplasty (TKA) patients.
The participants will be randomized in two groups: intervention group (IG) and control group (CG).
The IG will receive a 20 minute program of active tDCS (2mA intensity, anode placed on primary motor cortex controlateral to the TKA, cathode placed on controlateral supraorbital region) followed by a 30 minute exercise program, 5 days a week, for 2 consecutive weeks.
The CG will receive a 20 minute program of sham tDCS (15 seconds of activation and then no stimulation, same position of IG) followed by the same 30 minute exercise program, 5 days a week, for 2 consecutive weeks.
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)
盲法说明
Participant blinding: sham tDCS is provided by a 15 second activation (to perform initial sensation) and then no stimulation in the same areas and with the same cadence of the real tDCS.
Outcomes assessor blinding: the assessor who evaluates the participants doesn't know if the tDCS or sham tDCS will be or were performed.
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
- •signed informed consent
- •able to independently walk (with or without walk aids)
- •chronic painful TKA (more than 3 months)
- •Visual Analogic Scale for pain more than 3/10
- •No cognitive impairments (MMSE>24 or =24/30)
排除标准
- •intracranial metal devices, pacemakers or any implantable devices
- •cutaneous abnormalities on the stimulation sites
- •epilepsy (past or present)
- •neurological or psychiatric pathologies
- •cognitive impairment (MMSE<24/30)
- •no opioids abuse (past or present)
- •severe cardiopulmonary, renal or hepatic pathologies
- •pregnancy
- •known present TKA complications (e.g. infections, mobilization, etc...)
- •pain therapy modifications in the last 1 month
结局指标
主要结局
Change of neuropathic pain presence
时间窗: Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3)
Douleur Neuropathique 4 (DN4) scale From 0 to 10. If score \> 4: neuropathic pain presence. Higher the score, higher the chance of neuropathic pain presence.
Change of pain intensity
时间窗: Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3)
Visual Analogic Scale (VAS) From 0 (no pain) to 10 (worst pain). Higher the score, worse the outcome.
Change of pain characteristics
时间窗: Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3)
Pain detect questionnaire (PD-Q) From 0 to 38. 0-12 more than 75% chance of presence of nociceptive pain. 13-18 uncertain neuropathic pain presence. 19-38 more than 90% chance of neuropathic pain presence. Higher the score, higher the chance of neuropathic pain presence versus nociceptive pain presence.
次要结局
- QoL: Short Form 12(Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3))
- Knee function(Enrollment (T0), at 2 weeks (T1), at 1 month (T2), at 3 months (T3))