Brain Connectomic Mechanisms of Spinal Manipulative Therapy on LDH Analgesia Based on Multimodal MRI
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity Measured by the Visual Analog Scale (VAS)
研究概览
简要总结
Low back and leg pain caused by lumbar disc herniation (LDH) is common. Lever positioning manipulation (LPM) is a spinal manual therapy used to relieve this pain, but how it affects the brain is unclear. This study will compare active LPM with a sham procedure and use multimodal magnetic resonance imaging (MRI) to investigate changes in brain networks associated with pain relief.
A total of 84 adults with LDH will be randomly assigned in a 1:1 ratio to active LPM or sham LPM, with three sessions per week for 12 weeks. An additional 42 age- and sex-matched healthy adults will undergo baseline assessments without treatment. Participants with LDH will be assessed before treatment, immediately after the first session, at week 6, and at week 12. Outcomes include pain intensity, lumbar function, disability, adverse events, and MRI measures of functional and structural brain connectivity. The study aims to identify brain connectomic mechanisms associated with LPM-induced analgesia.
详细描述
This is a single-center, prospective, randomized, participant- and outcome-assessor-masked, sham-controlled study with a matched healthy control cohort. Eighty-four participants with lumbar disc herniation will be randomly allocated 1:1 to active lever positioning manipulation or sham lever positioning manipulation using a computer-generated block randomization sequence prepared by an independent statistician. Allocation will be concealed in sequentially numbered, opaque, sealed envelopes. Forty-two age- and sex-matched healthy controls will complete baseline clinical and MRI assessments only.
Active and sham treatments will be delivered three times weekly for 12 weeks, with approximately 20 minutes per session. The sham procedure will reproduce the treatment setting, participant position, preparatory procedures, and practitioner contact but will omit the rapid lever-pulling maneuver. Analgesics, neurotrophic drugs, sedatives, spinal manipulation, acupuncture, traction, and other therapies that could affect pain or MRI outcomes will be prohibited during the treatment period.
Participants with LDH will be assessed at baseline before randomization, immediately after the first treatment session, at week 6, and at week 12. The primary outcome is change in pain intensity measured by the Visual Analog Scale from baseline to week 12. Secondary clinical outcomes include lumbar function measured by the Japanese Orthopaedic Association score and disability measured by the Oswestry Disability Index. Multimodal MRI will be used to evaluate longitudinal changes in functional network topology, white-matter structural connectivity, and structure-function coupling. Exploratory analyses will examine gray-matter covariance and associations between clinical improvement and imaging changes. Safety will be assessed through adverse-event monitoring and vital-sign checks at each treatment session.
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
Participants and outcome assessors are masked to treatment allocation. Treating practitioners are not masked because of the nature of the manual intervention.
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
- •Patients with lumbar disc herniation (LDH):
- •Diagnosis of LDH based on clinical symptoms, physical examination findings, and lumbar imaging consistent with neurological localization; central, paracentral, far-lateral, foraminal, or subarticular lumbar disc protrusion.
- •Aged 18-65 years, of either sex, and right-handed.
- •In the non-acute phase of LDH, with symptom duration of more than 2 weeks.
- •Visual Analog Scale (VAS) score greater than 4 and Japanese Orthopaedic Association (JOA) score less than
- •No use of analgesics, neurotrophic drugs, or sedatives within 1 month before enrollment.
- •No systematic treatment, spinal manipulation, or other physical therapies within 1 month before enrollment.
- •Able to understand the study procedures and complete clinical assessments and MRI scans.
- •Provides written informed consent.
- •Healthy controls:
- •Aged 18-65 years, of either sex, and right-handed.
- •No history of LDH or chronic low back pain.
- •No current pain condition requiring treatment.
- •No neurological or psychiatric disorders.
- •No known structural brain abnormalities.
- •No MRI contraindications.
- •Able to complete clinical assessments and MRI scans.
- •Provides written informed consent.
排除标准
- •Patients with LDH:
- •Low back pain or sciatica caused by conditions other than LDH.
- •Lumbar spondylolisthesis, lumbar tumor, spinal tuberculosis, severe osteoporosis, or localized lumbar skin lesions that may interfere with treatment.
- •Severe cardiovascular, cerebrovascular, hepatic, renal, hematopoietic, neurological, or psychiatric disease.
- •History of severe head trauma, loss of consciousness, or known structural brain abnormality.
- •Impaired consciousness, severe visual or hearing impairment, speech disorder, or inability to complete clinical assessments.
- •Non-MRI-compatible metal implants, implanted electronic devices, cardiac pacemakers, severe claustrophobia, or inability to tolerate MRI scanning.
- •Asymptomatic LDH.
- •Pregnancy, lactation, or planned pregnancy during the study period.
- •Participation in another clinical trial within the previous 3 months.
- •Any condition judged by the investigators to make the patient unsuitable for participation.
- •Healthy controls:
- •Any condition that may affect eligibility, MRI safety, or data quality.
结局指标
主要结局
Change in Pain Intensity Measured by the Visual Analog Scale (VAS)
时间窗: Baseline, immediately after the first treatment session, week 6, and week 12; primary endpoint at week 12
Pain intensity will be assessed using the Visual Analog Scale (VAS). The prespecified primary endpoint is the between-group difference between active LPM and sham LPM in change from baseline to week 12. VAS will also be collected immediately after the first treatment session and at week 6.
次要结局
- Change in Lumbar Function Measured by the Japanese Orthopaedic Association (JOA) Score(Baseline, immediately after the first treatment session, week 6, and week 12)
- Change in Disability Measured by the Oswestry Disability Index (ODI)(Baseline, immediately after the first treatment session, week 6, and week 12)
- Change in Resting-State Functional Brain Network Topology(Baseline, immediately after the first treatment session, week 6, and week 12; main longitudinal comparison from baseline to week 12)
- Change in White-Matter Structural Connectivity(Baseline, immediately after the first treatment session, week 6, and week 12; main longitudinal comparison from baseline to week 12)
- Change in Brain Structure-Function Coupling(Baseline, immediately after the first treatment session, week 6, and week 12; main longitudinal comparison from baseline to week 12)
研究者
Lijiang Lv
Principal Investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University