Clinical Research Directory

Clinical Efficacy and Peripheral Ultrasound Mechanism of Trigger Point Bloodletting Therapy for Primary Trigeminal Neuralgia

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.

Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN

The goal of this clinical trial is to evaluate Gamma Knife stereotactic radiosurgery (GK-SRS) as an ultra-early treatment option for trigeminal neuralgia (TN). The main questions it aims to answer are: 1. will earlier GK-SRS provide more durable pain relief compared to later GK-SRS? 2. will earlier GK-SRS reduce or eliminate the need for high-dose medical therapy? 3. will earlier GK-SRS have a lower risk of serious complications compared to other first-line treatments? If participants are assigned to GK-SRS treatment group, they will be asked to: • Undergo a preoperative MRI, measurements of heart rate and blood pressure, stereotactic head-frame placement, post-operative management and observation. Both groups will be asked to: * Complete medical histories and neurological examinations. These are part of standard of care. * Participants will be asked a series of questions related to overall physical health, pain severity, and mood. Completing these questionnaires is part of the research activity. It will take approximately 15- 30 minutes to complete. These questionnaires include: The Barrow Neurological Institute Pain Intensity Score, Brief Pain Inventory-Facial (BPI-Facial), Visual Analog Scale (VAS), Medication Quantification Scale (MQS), Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), and the Short Form Health Survey.

Identification of Possible Trigeminal Neuralgia

Trigeminal neuralgia (TN) is a severe type of non-dental orofacial pain that can feel like sudden electric shocks in the face and is often mistaken for tooth pain or other dental problems. This can lead to delays in referral and unnecessary, sometimes irreversible, dental treatment. The goal of this observational study is to evaluate how well a new questionnaire (IDentification of possible Trigeminal Neuralgia - IDTN) identifies adults with possible trigeminal neuralgia among patients attending hospital clinics with orofacial pain, with the aim of supporting its use in dental and general medical practice to improve early recognition and referral. The main questions it aims to answer are: * How accurately does the IDTN questionnaire identify patients with possible trigeminal neuralgia compared with the specialist clinical diagnosis? * Which combination of questionnaire items best supports a practical screening score for use in dental and/or general medical practice? Participants will: 1. Complete the IDTN questionnaire before their clinical appointment (either electronically or on paper) 2. Undergo their usual specialist clinical assessment, during which the final diagnosis will be recorded 3. Allow the research team to compare questionnaire responses with the specialist diagnosis (the reference standard) A subset of participants will also be asked to complete the questionnaire again a few days later to assess test-retest reliability.

Magnetic Resonance Imaging in Patients with Trigeminal Neuralgia

This study intends to use MRI technology to analyze the dynamic changes and microstructure changes of the brain network in patients with trigeminal neuralgia, evaluate the blood-brain barrier and water exchange rate, and further analyze their correlation with clinical indicators, so as to explore the changes in brain structural plasticity and potential neural mechanisms