Treatment of Chronic Non-specific Low Back Pain With Brain and Peripheral Electrical Stimulation: a Factorial, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of brain and peripheral electrical stimulation on chronic non-specific low back pain patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged > 18 years and <65 years
- •Complaining of back pain for more than three months
- •Presence of a chronic pain measurable with the number rating scale (NRS 0-10) not less than 4 during a 1 week daily NRS monitoring
- •Seeking care for low back pain
排除标准
- •Previous surgery on the spine, spondylolisthesis
- •Previous treatment with TENS <6 months
- •Previous treatment with tDCS
- •Disc herniation with nerve compression
- •Neurological, psychiatric and rheumatologic diseases
- •Impaired sensibility
- •Use of pacemakers or other implanted devices
- •Pregnancy
研究组 & 干预措施
tDCS real + TENS real
Real transcranial direct current stimulation associated with real transcutaneous electrical nerve stimulation (TENS).
tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
TENS: 40 minutes, 100Hz, 200µs, 2 channels with electrodes over the low back area of pain.
干预措施: Transcranial direct current stimulation (tDCS) (Procedure)
tDCS real + TENS real
Real transcranial direct current stimulation associated with real transcutaneous electrical nerve stimulation (TENS).
tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
TENS: 40 minutes, 100Hz, 200µs, 2 channels with electrodes over the low back area of pain.
干预措施: Transcutaneous electrical nerve stimulation (TENS) (Procedure)
tDCS real + TENS sham
Real transcranial direct current stimulation associated with sham transcutaneous electrical nerve stimulation (TENS).
tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
TENS: 40 minutes (30 seconds ON), 100Hz, 200µs, 2 channels with electrodes over the low back area of pain.
干预措施: Transcranial direct current stimulation (tDCS) (Procedure)
tDCS real + TENS sham
Real transcranial direct current stimulation associated with sham transcutaneous electrical nerve stimulation (TENS).
tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
TENS: 40 minutes (30 seconds ON), 100Hz, 200µs, 2 channels with electrodes over the low back area of pain.
干预措施: Transcutaneous electrical nerve stimulation (TENS) (Procedure)
Sham tDCS + Sham TENS
Sham transcranial direct current stimulation associated with sham transcutaneous electrical nerve stimulation (TENS).
tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
TENS: 40 minutes (30 seconds ON), 100Hz, 200µs, 2 channels with electrodes over the low back area of pain.
干预措施: Transcranial direct current stimulation (tDCS) (Procedure)
Sham tDCS + Sham TENS
Sham transcranial direct current stimulation associated with sham transcutaneous electrical nerve stimulation (TENS).
tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
TENS: 40 minutes (30 seconds ON), 100Hz, 200µs, 2 channels with electrodes over the low back area of pain.
干预措施: Transcutaneous electrical nerve stimulation (TENS) (Procedure)
tDCS sham + TENS real
Sham transcranial direct current stimulation associated with real transcutaneous electrical nerve stimulation (TENS).
tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
TENS: 40 minutes, 100Hz, 200µs, 2 channels with electrodes over the low back area of pain.
干预措施: Transcranial direct current stimulation (tDCS) (Procedure)
tDCS sham + TENS real
Sham transcranial direct current stimulation associated with real transcutaneous electrical nerve stimulation (TENS).
tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
TENS: 40 minutes, 100Hz, 200µs, 2 channels with electrodes over the low back area of pain.
干预措施: Transcutaneous electrical nerve stimulation (TENS) (Procedure)
结局指标
主要结局
Pain intensity
时间窗: Four weeks after randomization
Pain intensity will be evaluated by numerical rating scale (0-10).
次要结局
- Quality of pain(4 weeks, 3 and 6 months after randomization.)
- Disability(4 weeks, 3 and 6 months after randomization.)
- Pain intensity(3 and 6 months after randomization)
- Global perceived effect (GPE)(4 weeks, 3 and 6 months after randomization.)