NCT03864822已完成不适用
Enhancing Inhibition With tDCS in Low Back Pain
Aalborg University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年4月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Conditioned Pain Modulation
研究概览
简要总结
This cross-over study intends to use consecutive days of active versus sham transcranial direct current stimulation (tDCS) to enhance descending inhibition and look at resulting clinical effects in people with low back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Stimulation type will be randomized by a colleague not involved in the study. A single investigator will assess all outcomes on all participants before and after each phase of stimulation, but participants not the investigator will be aware of Active/Sham assignment until after study completion
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Otherwise healthy men and women
- •Aged 18-60 years
- •Continuous pain (>3days pain/week) episode lasting at least 3 months, sufficient to limit daily activities
- •Pain in the region posteriorly between the inferior border of the 12th rib and the lower gluteal fold (low back pain) at the time of recruitment
- •Able to speak, read and understand English
排除标准
- •Pregnancy
- •Low back pain associated with menstruation
- •Currently seeking active treatment for low back pain
- •Red flags symptoms (i.e. fever, malaise, progressive neurologic deficit, significant trauma, prolonged corticosteroid use or osteoporosis, pain worst at night, urinary or faecal incontinence, or unintended weight loss)
- •Drug addiction defined as the use of cannabis, opioids or other drugs
- •Current or previous neurologic, musculoskeletal, mental, or other illnesses which may affect the trial
- •Current or previous chronic or recurrent pain condition other than low back pain
- •Current regular use of analgesic medication or other medication which may affect the trial
- •Lack of ability to cooperate
结局指标
主要结局
Conditioned Pain Modulation
时间窗: Day 0 (Pre) to Day 3 (Post) in each stimulation phase
Change in cuff pain threshold with contralateral cuff conditioning stimulus
次要结局
- Temporal Summation of Pain(Day 1 (Pre) to Day 3 (Post) in each stimulation phase)
- Pressure Pain Thresholds(Day 1 (Pre) to Day 3 (Post) in each stimulation phase)
- Pain Intensity(Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase)
- Pain Unpleasantness(Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase)
- Pain Area(Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase)
- Roland-Morris Disability Questionnaire(Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase)
- Back Performance Scale(Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase)
研究者
Megan McPhee
Principal Investigator
Aalborg University
研究点 (2)
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