Study on Clinical Efficacy and Peripheral Ultrasound Mechanism of Trigger Point Bloodletting Therapy for Primary Trigeminal Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Brief Pain Inventory-Facial total score
研究概览
简要总结
This randomized controlled trial integrates baseline observational ultrasound analysis to assess the clinical efficacy of trigger point bloodletting therapy for primary trigeminal neuralgia and explore peripheral ultrasound mechanisms of trigger point lesions and treatment response. Eligible subjects are adults aged 18-75 with unilateral classic primary trigeminal neuralgia and confirmed trigger points in the orbicularis oris muscle.
The primary research question is whether 8-week trigger point bloodletting achieves a greater reduction in Brief Pain Inventory-Facial total score (primary endpoint) than oral carbamazepine. Secondary questions explore inter-side differences in orbicularis oris thickness, elasticity and microvascular perfusion, correlations between ultrasound biomarkers, pain severity and disease duration, as well as differential dynamic ultrasound changes under the two treatments and their links to pain relief.
Participants complete baseline assessments: demographic data, medical history, pain, anxiety, depression and quality-of-life scales, trigger point mapping, and bilateral orbicularis oris ultrasound (grayscale imaging, shear wave elastography, superb microvascular imaging). Subjects are randomly assigned 1:1 to bloodletting intervention or carbamazepine control for 8 weeks. The bloodletting group receives twice-weekly sterile trigger point pricking with cupping bleeding at suitable sites. The control group takes guideline-based individualized carbamazepine, with all subjects maintaining daily pain and medication diaries.
Follow-up evaluations occur at Weeks 2, 4, 6 and 8, covering pain scoring, trigger point re-evaluation and adverse event monitoring. Post-treatment bilateral orbicularis oris ultrasound is performed at Week 8 to quantify changes in soft tissue structure and microcirculation. All adverse reactions and concurrent medications are documented throughout the trial. Baseline observational analysis compares pretreatment bilateral facial muscle ultrasound features and correlates imaging indicators with clinical pain, to provide objective imaging evidence for peripheral sensitization pathology of trigger points in trigeminal neuralgia patients.
详细描述
The goal of this randomized controlled clinical trial with embedded observational baseline analysis is to evaluate the clinical efficacy of trigger point bloodletting therapy for primary trigeminal neuralgia and explore peripheral musculoskeletal ultrasound mechanisms of trigger point lesions and treatment response. This study enrolls adult participants aged 18 to 75 years with unilateral classic or idiopathic primary trigeminal neuralgia and definite trigger points located in the upper lip orbicularis oris muscle.
The main questions it aims to answer are:
Does eight weeks of trigger point bloodletting therapy deliver a larger decline in Brief Pain Inventory Facial total score which serves as the primary efficacy endpoint compared with routine oral carbamazepine treatment among participants with primary trigeminal neuralgia? Do orbicularis oris muscle ultrasonographic indicators including soft tissue thickness elasticity and microvascular blood flow present discrepancies between affected sides and contralateral unaffected sides, and do these imaging indicators correlate with pain severity and disease course length? Do the two intervention regimens lead to distinct dynamic variations in orbicularis oris muscle ultrasound parameters, and do such structural and microcirculation variations correlate with clinical pain relief degrees? Researchers will compare participants receiving trigger point bloodletting intervention and participants receiving carbamazepine control treatment to identify whether trigger point bloodletting therapy yields better pain relief and more obvious recovery of soft tissue structure and microcirculation in trigger point regions.
Participants will finish all scheduled study procedures within an eight week treatment cycle as follows Complete baseline screening and systematic assessments covering demographic information medical history collection clinical pain evaluation and quality of life scale measurement. Scales adopted include Brief Pain Inventory Facial visual analogue scale self rating depression scale self rating anxiety scale and the 36 Item Short Form Health Survey. Researchers conduct full range trigger point localization feature recording and bilateral orbicularis oris muscle ultrasound detection. Ultrasound detection includes grayscale imaging shear wave elastography and superb microvascular imaging modules.
Receive random grouping allocation at a one to one ratio to either trigger point bloodletting group or carbamazepine control group.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 18 to 75 years old
- •Participants diagnosed with primary trigeminal neuralgia
- •Participants with definite facial trigger points located in the orbicularis oris muscle of upper lip
- •Participants whose pain meets the diagnostic criteria of classic or idiopathic primary trigeminal neuralgia
- •Participants with visual analogue scale pain score no less than 4 at screening
- •Participants who can understand scale evaluation and complete follow-up visits on schedule
- •Participants sign written informed consent voluntarily
排除标准
- •Secondary trigeminal neuralgia caused by tumor vascular compression inflammation or other organic lesions
- •History of facial surgery radiofrequency ablation or nerve block treatment within three months
- •Receiving acupuncture bloodletting or similar physical therapy on facial region within one month
- •Severe uncontrolled systemic diseases including heart liver kidney and hematological disorders
- •Coexisting mental disorders that affect pain assessment and follow up Pregnant or lactating women
- •Known allergy to carbamazepine or bloodletting operation contraindications such as coagulation dysfunction
- •Participants who are unable to cooperate with ultrasound examination
研究组 & 干预措施
Trigger Point Bloodletting Therapy Group
Participants receive standardized trigger point bloodletting therapy for 8 consecutive weeks.
干预措施: Trigger Point Bloodletting Therapy (Procedure)
Oral Carbamazepine Control Group
Participants receive individualized oral carbamazepine treatment for 8 consecutive weeks.
干预措施: Carbamazepine (Drug)
结局指标
主要结局
Change in Brief Pain Inventory-Facial total score
时间窗: Baseline to 8 weeks after intervention initiation
Full unabbreviated scale title: Brief Pain Inventory-Facial. Total score minimum value = 0, maximum value = 100. This item measures the change in total score from baseline to the 8-week endpoint. Higher scores indicate more severe facial pain (worse outcome), lower scores indicate milder facial pain.
次要结局
- Change in Visual Analogue Scale pain score(Baseline to 2 weeks, 4 weeks, 6 weeks, 8 weeks)
- Change in orbicularis oris muscle soft tissue thickness(Baseline to 8 weeks)
- Change in orbicularis oris muscle shear wave elasticity(Baseline to 8 weeks)
- Change in orbicularis oris muscle microvascular blood flow signal(Baseline to 8 weeks)
研究者
Xiaoyan Li
Physician
Beijing Hospital of Traditional Chinese Medicine