Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Periaqueductal Gray (PAG) Resting State Functional Connectivity (rsFC) Changes
研究概览
简要总结
In this study, investigators will examine the brain mechanism behind the synergistic effects of combining acupuncture and transcranial direct current stimulation (tDCS) treatments. Specifically, chronic low back pain (cLBP) patients will be recruited and randomized to one of four groups (30 per group, one month of treatment): 1) verum acupuncture + real tDCS, 2) sham acupuncture + real tDCS, 3) verum acupuncture + sham tDCS, and 4) sham acupuncture + sham tDCS. Investigators will study 1) the longitudinal (one-month) effects of different treatments as indicated by changes in resting state functional connectivity (rsFC), cerebral blood flow (CBF), clinical outcomes of low back pain, and quantitative sensory test (QST) and 2) the association between these changes.
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, Investigator)
盲法说明
Both participants and study staff will be blinded to the treatment group of participants. Only the licensed acupuncturist will be aware of the type of acupuncture the participant will be receiving.
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
- •volunteers 18-60 years of age
- •meet the classification criteria of chronic low back pain (having low back pain for more than 6 months), as determined by the referring physician
- •at least 4/10 clinical pain on the 11-point Low Back Pain Numeric Rating Scale (LBP NRS)
- •at least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures
排除标准
- •history of epilepsy or loss consciousness (LOC)
- •specific causes of back pain (e.g. cancer, fractures, spinal stenosis, infections)
- •complicated back problems (e.g. prior back surgery, medicolegal issues)
- •the intent to undergo surgery during the time of involvement in the study
- •history of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcomes. For example: asthma or claustrophobia
- •presence of any contraindications to magnetic resonance imaging (MRI) scanning. For example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, inability to remain still in MRI scanner
- •history of medical or psychiatric illness as determined by the investigator
- •history of substance abuse or dependence
结局指标
主要结局
Periaqueductal Gray (PAG) Resting State Functional Connectivity (rsFC) Changes
时间窗: difference between Day 1 (pre-intervention); post-intervention at Week 4 (pre-intervention - Post-intervention)
We investigated whether tDCS and acupuncture treatments modulate resting-state functional connectivity (rsFC) of the periaqueductal gray (PAG). This was evaluated by comparing pre- and post-treatment MRI scans. In this report, we focused on the rsFC between the PAG and the rostral anterior cingulate cortex (rACC, peak MNI coordinate (2, 38, 12) with a 2-mm radius sphere). Functional connectivity values were computed as Pearson's correlation coefficients between the mean time series of predefined regions of interest (ROIs). To improve normality and enable parametric statistical analysis, these correlation coefficients (r) were converted to Fisher z values using the transformation z = 0.5 × ln\[(1 + r) / (1 - r)\]. Higher Fisher z values indicate stronger positive connectivity, whereas lower values indicate weaker or negative connectivity. Changes in Fisher z values from baseline to post-intervention reflect the degree and direction of connectivity modulation.
次要结局
- Cerebral Blood Flow (CBF) Differences Before and After Treatments(Day 1 (pre-intervention); post-intervention at Week 4)
- Clinical Outcomes as Measured by LBP Intensity Scores(Difference between the Day 1 (pre-intervention) and post-intervention at Week 4 (post-intervention - pre-intervention))
- Cerebral Blood Flow (CBF) Differences Before and After Treatments(Day 1 (pre-intervention); post-intervention at Week 4)
- Quantitative Sensory Testing (QST) Differences(Day 1 (pre-intervention); post-intervention at Week 4 (pre-intervention - post-intervention))
- Primary Motor Cortex (M1) rsFC Changes Before and After 4-week Treatments(Day 1 (pre-intervention); post-intervention at Week 4 (pre-intervention - post-intervention))
研究者
Jian Kong
Associate Professor, Associate Researcher
Massachusetts General Hospital