Comparison of the Effectiveness of Trigeminocervical Complex Peripheral Branch Blockade and Neuromodulation Methods With Peripheral Blood CGRP and PACAP38 Levels in Patients With Chronic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The aim of this study is to investigate the effectiveness of nerve block and radiofrequency treatments in patients with chronic migraine using biochemical migraine biomarkers
研究概览
简要总结
The study included 100 patients diagnosed with chronic migraine (CM) who received a diagnosis from the headache clinics of the Neurology Department of Adnan Menderes University Hospitals between May 2025 and May 2026. Inclusion criteria were patients over 18 years of age with chronic migraine. Written informed consent was obtained from all participants; patients with severe systemic diseases, occiput infections or injuries, and allergies to any of the substances used in the injection were excluded. All patients were clinically evaluated (detailed history including personal data, medical history, and migraine treatments used). All patients underwent ultrasound-guided bilateral GON blockade using a portable ultrasound system with a 7-13 MHz multifrequency transducer (ACUSON Juniper Ultrasound System, Siemens, Germany). Blood samples were collected before and one month after the procedure. Samples were collected between 9 and 11 am to avoid the effect of circadian rhythms on CGRP levels. Patients will need to discontinue any anti-inflammatory or analgesic medication within the last 48 hours. A blood sample will be taken from the non-dominant forearm to measure interictal serum CGRP-PACAP38 levels using commercial ELISA kits (Novus Biologicals Inc., USA) according to the manufacturer's instructions. Absorption levels will be measured with a spectrophotometer at a wavelength of 450 nm ± 2 nm. The detection limit for CGRP is 9.3 pg/mL.
详细描述
Preoperative Visit:
During the preoperative visit, patients' additional illnesses, demographic data, and medication use will be recorded. The patients' NRS (Numerating Rating Scale) score will be recorded. Antebrachial venous blood samples will be taken along with routine samples requested after the outpatient examination.
Intraoperative Nerve Block Procedure:
All procedures were planned to be performed under sterile conditions with ultrasound guidance while the patient was in the prone position.
GON Block: The ultrasound probe was placed in a transverse plane 2-3 cm lateral to the Protuberantio Ocipitalis Externa. After visualizing the occipital artery, it was targeted medial to the GON artery. After local anesthesia with 1% lidocaine (skin-subcutaneous), a 21 Gauge 5 cm long needle tip was guided from lateral to medial using an in-plane approach to precisely place it in the center of the nerve for the block (Figure 2). After negative acission, the block was performed with 3 ml of 2% Prilocaine. Supraorbital/supratrochlear nerve block: The ultrasound probe is placed along the supraorbital notch, through the medial third of the supraorbital border. The supraorbital nerve (SON) and the supratrochlear nerve (STN) are located just above its medial border. 2 cc of 2% prilocaine is injected into the target using a 5 cm, 21 gauge needle and inplane technique.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being over 18 years of age
- •Having given written consent
- •Patients diagnosed with chronic migraine
排除标准
- •Major psychiatric illness
- •Patients using anticoagulant agents
- •4. Patients with infection in the procedure area
- •Patients allergic to local anesthetics
- •Pregnant women
- •Patients with cardiac pacemakers
研究组 & 干预措施
patients to whom applied radiofrequency
For radiofrequency, a 5 cm long RF cannula with a 5 mm active tip is placed in the target under ultrasound guidance, and the needle tip is guided from laterally to medially using an inplane approach to precisely center the nerve. To induce a congruent paresthesia response in the occipital nerve distribution, 50 Hz 1v sensory and 2 Hz 2v motor electrical stimulation was performed with an SMK (Select RF StraightCannula, 100mm, 22G, 10mm active tip SMK-S1010-22) RF electrode. Pulsed radiofrequency (Neurotherm NT1100 / 13001-12) will be applied at 42°C for 240 second
干预措施: Greater occipital nerve Pulse radiofrequency (Procedure)
patients to whom applied greater occipital nerve block
The ultrasound probe was placed in a transverse plane 2-3 cm lateral to the Protuberantio Ocipitalis Externa. After visualizing the occipital artery, it was targeted medial to the GON artery. After local anesthesia with 1% lidocaine (skin-subcutaneous), a 21 Gauge 5 cm long needle tip was guided from lateral to medial using an in-plane approach to precisely place it in the center of the nerve for the block (Figure 2). After negative acission, the block was performed with 3 ml of 2% Prilocaine. Supraorbital/supratrochlear nerve block: The ultrasound probe is placed along the supraorbital notch, through the medial third of the supraorbital border. The supraorbital nerve (SON) and the supratrochlear nerve (STN) are located just above its medial border. 2 cc of 2% prilocaine is injected into the target using a 5 cm, 21 gauge needle and inplane technique.
干预措施: Greater occipital nerve block (Procedure)
结局指标
主要结局
The aim of this study is to investigate the effectiveness of nerve block and radiofrequency treatments in patients with chronic migraine using biochemical migraine biomarkers
时间窗: 1 month
It was planned to measure venous blood CGRP and PACAP38 levels in patients with chronic migraine before the interventional procedure and one month after the procedure.
次要结局
- The secondary outcome of this study is to compare the effectiveness of nerve block and radiofrequency treatments on chronic pain in patients with chronic migraine.(6 months)
研究者
Esra Ertilav
Assoc. Prof.
Aydin Adnan Menderes University