- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05199064
Efficacy of Greater Occipital Nerve Radiofrequency for Refractory Migraine Treatment
Efficacy of Ultrasound Guided Greater Occipital Nerve Pulsed Radiofrequency Therapy in Chronic Refractory Migraine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Design and Study Population:
The ethical approval of the current study was obtained from the Local Ethics Committee of Tepecik Education and Research Hospital. In this study, 25 patients who were diagnosed as having chronic refractory migraine and were refractory to conventional treatments, such as oral medications, GONB,and botulinum toxin injection were evaluated.All patients received pulsed RFtherapy to the GON from the proximal (C2) level in the pain clinic between September 2020 and September 2021. In the current study, patients who were highly likely to have a chronic systemic disease that might be the cause of headache, such as hypertension, were excluded from the study. Additionally, patients who already had other primary headache conditions were also excluded.
To assess the outcomes of the intervention, the patients were evaluated in terms of Beck'sDepression Inventory (BDI) scores,Migraine Disability Assessment Score (MIDAS), visual analog scale (VAS) scores, and Pittsburgh Sleep Quality Index (PSQI) scores.VASsare measurement instruments that try to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. They are often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. MIDAS is a brief, self-administered questionnaire designed to quantify headache-related disability over 3 months. The MIDAS score has been shown to have moderately high test-retest reliability in patients with headaches. Psychological symptoms often coexist in patients with migraine. Symptoms of depression may reinforce comorbidity between depression and chronic refractory migraine. Therefore, we used BDI scores .The PSQI was developed by Buysse et al. It provides a quantitative measurement of sleep quality to identify good and poor sleep. We wanted to evaluate sleep quality in our patients because chronic pain negatively affects sleep quality .These scoring concepts were used preintervention, and at the post interventional 1st and 3rd months. Afterward, whether the patients benefited from the intervention was assessed by subtracting the preintervention score from the post interventional 1st-month score, and the pre intervention score from the post interventional 3rd-month score. Demographic data of all patients, the side of the pain, and the monthly attack frequency and duration were noted.
The treatment was performed in the local operating room under sterile conditions, accompanied by ultrasonographic imaging with a linear probe (6-12-Mhz Philips DC7 color Doppler ultrasound machine), in the prone position, at the C2 level, with the head slightly flexed. No sedation is needed for this intervention.We start visualizing from the occipital protrusion,then we slide the probe inferiorly to find the first bifid spinous process of C2. After finding the C2 level, we move the probe laterally (towards the side where we will use the RF) to identify the obliquus capitis inferior muscle and semispinalis capitis muscle of the neck .The GON is found superficial to the obliquus capitis inferior muscle and deeperto the semispinalis capitis muscle at this level. After identifying the GON, a catheter needle (22-gauge 5 cm 5 mm active tip hybrid electrode) is inserted with an in-plane technique from lateral to medial. After visualizing the electrode tip placed close to the right or left GON, a sensory stimulation test is performed using an RF generator . After the patient reports dysesthesia and a tingling sensation at the occipital area with less than 0.2 V, the Pulsed RF treatment is administered at 5 Hz and 5 milliseconds pulsed width for 360 seconds at 45 V under the constraint that the temperature of the electrode tips does not exceed 42°C
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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İzmir, Turkey, 35000
- Tepecik Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Chronic refractory migraine patients
Exclusion Criteria:
Other primer headache disorders, İntracranial lesion, Bleeding disorders.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Chronic refractory migraine patients
25 patients who were diagnosed as having chronic refractory migraine and were refractory to conventional treatments, such as oral medications, GONB,and botulinum toxin injection were evaluated.All patients received pulsed RFtherapy to the GON from the proximal (C2) level in the pain clinic between September 2020 and September 2021.
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After identifying the GON with ultrasound guidance, a catheter needle (22-gauge 5 cm 5 mm active tip hybrid electrode) is inserted with an in-plane technique from lateral to medial.After visualizing the electrode tip placed close to the right or left GON, a sensory stimulation test is performed using an RF generator (URF-3AP Diros Tecnology Inc.).
After the patient reports dysesthesia and a tingling sensation at the occipital area with less than 0.2 V, the PRF treatment is administered at 5 Hz and 5 milliseconds pulsed width for 360 seconds at 45 V under the constraint that the temperature of the electrode tips does not exceed 42°C
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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GON pulsed radiofrequency therapy applied from the proximal level under ultrasound guidance is effective and safe.
Time Frame: 3 months
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The aim of our study to evaluate the clinical responses of patients with chronic migraine who underwent pulsed Radiofrequency therapy at the C2 level under ultrasound guidance.GON pulsed radiofrequency therapy applied under the guidance of ultrasound benefited all our patients and no side effects were observed.
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3 months
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GON pulsed radiofrequency therapy applied from the proximal level under ultrasound guidance provides positive effects on quality of life, depression and sleep.
Time Frame: 3 months
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GON RF treatment provided significant improvement in the scores (BDI,MIDAS, VAS and PSQI) of all patients withmigraine in our study.
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3 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tepecik TRH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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