The Effects of High-definition Transcranial Direct Current Stimulation on Balance Control in Older Adults With Chronic Low Back Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Current back-pain intensity
研究概览
简要总结
The goal of this clinical trial is to investigate the effects and mechanisms of high-definition transcranial direct current stimulation over left dorsolateral prefrontal cortex on chronic low back pain and balance in older adults. The main questions it aims to answer are:
Primary hypothesis 1: Active stimulation would have greater improvement in pain and balance, reduced left dorsolateral prefrontal cortex activation than sham stimulation.
Primary hypothesis 2: Active stimulation would have enhanced functional connectivity than sham stimulation.
Primary hypothesis 3: The balance improvement would be related to reduced pain, decreased left dorsolateral prefrontal cortex activation, enhanced functional connectivity, attention, and/or executive function.
Participants will be randomly received a single-session of high-definition transcranial direct current stimulation (active or sham stimulation). Before and immediately after the intervention, balance (semi-tandem stance and timed up-and-go test (TUG)) and cognitive (attention and executive function) tests will be assessed.
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
The allocation of the participants will be sealed in an envelope, blinding the subjects and assessors, and a third person (intervention implementer) will perform the blinding.
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 60-85 years;
- •With non-specific chronic low back pain that has no definitive diagnosis but lasted for at least 3 months, typically occurs in the area between the lower rib margins and the buttock creases;
- •With an average pain intensity over the last week to be ≥ 3 on an 11-point numerical rating scale (NRS) anchored with "no pain" at zero and "worst pain imaginable" at 10;
- •Have normal cognitive function (Hong Kong Montreal Cognitive Assessment ≥ 22);
- •Who agree to sign an informed consent form.
排除标准
- •Inability to ambulate without assistance from another person or tools (e.g., canes or walkers);
- •Having specific causes of low back pain (e.g., spinal stenosis, lumbar disc herniation, spondylolisthesis, recent vertebral fracture, spinal infection);
- •Having other acute or overt musculoskeletal conditions in other parts of the body (e.g., fractures, severe pain, multiple joint pain (e.g., knee pain));
- •History of lumbar or lower extremity surgery;
- •Receiving LBP treatment within the past one month or at present;
- •Have never received non-invasive brain stimulation (e.g., transcranial direct current stimulation, repetitive transcranial magnetic stimulation, and transcranial alternating current stimulation) before.
研究组 & 干预措施
Active stimulation
For the active stimulation, the current will be ramped up from 0 to 2 mA over the initial 30-s period and then maintain the current of 2 mA for 20 minutes, following by a 30-s ramp-down period.
干预措施: high-definition transcranial direct current stimulation (Device)
Sham stimulation
The participants will receive the same intervention procedures, but the intervention will have no therapeutic effect. Specifically, for the sham stimulation, participants will only experience 30-s ramp-up and 30-s ramp-down periods at both the commencement and end of the stimulation.
干预措施: high-definition transcranial direct current stimulation (Device)
结局指标
主要结局
Current back-pain intensity
时间窗: Before and immediately after the intervention.
The current back-pain intensity will be assessed with the 11-point numerical rating scale anchored with "no pain" at zero and "worst pain imaginable" at 10.
次要结局
- Resting-state blood oxygen concentration(Before and immediately after the intervention.)
- Arithmetic performance(Before and immediately after the intervention.)
- Postural sway(Before and immediately after the intervention.)
- Timed up-and-go test (TUG)(Before and immediately after the intervention.)
- Attention(Before and immediately after the intervention.)
- Executive function(Before and immediately after the intervention.)
- Side or adverse effects(During and 1 hour after the intervention.)
- Blinding efficacy(Immediately after the intervention.)
研究者
Dr Arnold Wong Yu Lok
Associate Professor
The Hong Kong Polytechnic University