Brain Effect Mechanism of Spinal Manipulative Therapy on Lumbar Disc Herniation Analgesia Based on Multimodal Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Magnetic Resonance Spectrum （MRS）
研究概览
简要总结
The clinical symptoms of Lumbar Disc Herniation (LDH) can be effectively ameliorated through Spinal Manipulative Therapy (SMT), which is closely linked to the brain's pain-regulating mechanisms. Magnetic Resonance Imaging (MRI) offers an objective and visual means to study how the brain orchestrates the characteristics of analgesic effects. From the perspective of multimodal MRI, the investigators applied functional MRI (fMRI) and Magnetic Resonance Spectrum (MRS) techniques to comprehensively evaluate the characteristics of the effects of SMT on the brain region of LDH from the aspects of brain structure, brain function and brain metabolism. This multimodal MRI technique provides a biological basis for the clinical application of SMT in LDH.
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
- Single (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
- 是
入选标准
- •Participants must meet the diagnostic criteria for lumbar disc herniation, including protrusion types such as central, paracentral, far lateral, foraminal, and subarticular, with imaging findings that align with neurological localization.
- •The age range for participants is 18 to 65 years, encompassing any gender, and they must be right-handed.
- •Participants should be in the non-acute phase of the condition, experiencing mild to moderate pain and functional impairment, with the duration of symptoms exceeding 2 weeks.
- •Participants should have a Visual Analog Scale (VAS) score greater than 4 and Japanese Orthopaedic Association (JOA) scores less than
- •Eligible participants must not have taken analgesics, neurotropic nutrition drugs, or sedatives in the past month and should not have undergone systemic treatment.
- •Participants should not have received spinal manipulation or other physical therapies in the past month.
- •Participants must voluntarily agree to participate in this study and have signed an informed consent form.
排除标准
- •Patients with concurrent internal medicine or gynecological conditions known to cause lower back pain, such as nephritis, urinary stones, gynecological inflammations, and uterine abnormalities.
- •Individuals with severe primary diseases impacting the cardiovascular, cerebrovascular, liver, or kidney systems.
- •Those with neurogenic functional disorders, psychiatric conditions, a history of significant head trauma, or a history of unconsciousness.
- •Individuals diagnosed with primary sciatica or dry sciatica.
- •Those with lumbar spondylolisthesis.
- •Patients suffering from lumbar tumors or tuberculosis.
- •Individuals with severe osteoporosis or localized skin lesions in the lumbar area.
- •Patients experiencing painful conditions beyond the lumbar region.
- •Those with diseases characterized by structural changes in the brain.
- •Individuals with impaired consciousness, severe visual or hearing impairments, speech disorders, or others who are unable to complete health assessments.
- •Individuals with dental implants, metal stents, or other elements that may compromise MRI imaging.
- •Those with a fear of MRI or other reasons that prevent undergoing MRI scans.
- •Patients diagnosed with lumbar disc herniation but who are asymptomatic.
结局指标
主要结局
Magnetic Resonance Spectrum （MRS）
时间窗: up to one month
The MRS Is the only technology capable of non-invasive quantitative detection of brain substance changes.
visual analogue scale (VAS)
时间窗: up to one month
Pain intensity was evaluated by means of a visual analogue scale (VAS) \[10-point visual analogue scale: 0 = no pain; 10 = very severe pain\].
Japanese Orthopaedic Association Scores (JOA)
时间窗: up to one months
Japanese Orthopaedic Association Scores (JOA), ranging from 0 (worst) to 100 (best), was used to evaluate the clinical state.
Amplitude of Low-Frequency Fluctuation (ALFF)
时间窗: up to one months
The ALFF measures the activity of neurons in the brain that are not affected by external factors.
Regional Homogeneity (ReHo)
时间窗: up to one months
The ReHo measures the consistency of the local functional activities of the brain's various regions.
Functional Connectivity (FC)
时间窗: up to one months
The FC represents the strength Of functional connections between brain regions, and can reflect the temporal correlation between the Region Of Interest (ROI) and the whole brain networking function.
次要结局
未报告次要终点
研究者
Zhou Xingchen
Prof.
The Third Affiliated hospital of Zhejiang Chinese Medical University