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

NCT07750730 | Not Yet Recruiting DMC

• 2 other identifiers: 2024BL02-027-02ZLRK202324
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trigeminal Neuralgia (TN)

Outcome Measures

Primary Outcomes (1)

• Change in Brief Pain Inventory-Facial total score

  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.

  Baseline to 8 weeks after intervention initiation

Secondary Outcomes (4)

• 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

Other Outcomes (1)

• Incidence of adverse events

  Within 8 weeks after intervention start

Study Arms (2)

Trigger Point Bloodletting Therapy Group

EXPERIMENTAL

Participants receive standardized trigger point bloodletting therapy for 8 consecutive weeks.

Procedure: Trigger Point Bloodletting Therapy

Oral Carbamazepine Control Group

ACTIVE COMPARATOR

Participants receive individualized oral carbamazepine treatment for 8 consecutive weeks.

Drug: Carbamazepine

Interventions

Trigger Point Bloodletting Therapy PROCEDURE

Sterile disposable bloodletting needles are used for pricking at confirmed facial trigger points of patients with primary trigeminal neuralgia. Cupping-assisted bleeding is conducted at anatomically appropriate regions. The treatment is delivered twice weekly for 8 consecutive weeks, with an interval of no less than two days between two adjacent treatment sessions.

Also known as: Trigger Point Pricking, Cupping Bloodletting

Trigger Point Bloodletting Therapy Group

Carbamazepine DRUG

Participants receive oral carbamazepine tablets. The dosage is adjusted individually according to clinical guidelines to control pain symptoms, and the maximum daily dose does not exceed 1.2 g. The treatment lasts continuously for 8 weeks.

Also known as: Carbamazepine Oral Administration

Oral Carbamazepine Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Capital Medical University Affiliated Beijing Hospital of Traditional Chinese Medicine

Beijing, Beijing Municipality, 250012, China

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Carbamazepine

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Huilin Liu, Dr

CONTACT

8618827062868; 306916598@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-07

Locations

CN (1)