Efficacy of Greater Occipital Nerve Radiofrequency for Refractory Migraine Treatment

NCT05199064 | Completed

• 1 other identifier: Tepecik TRH
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Ultrasound-guided pulsed radiofrequency therapy can be used on the greateroccipital nerve (GON) in patients with chronic migraine (CM) who are unresponsive to conservative treatments. In this study, we aimed to demonstrate the change in pain intensity, duration of migraine episodes, frequency of attacks,migraine disability, depression,and sleep disturbance scores before and after treatment in patients with CM who underwent ultrasound-guided GON pulsed radiofrequency and the effectiveness of treatment. Patients and methods:The study included 25 patients who were diagnosed as having CMaccording to the International Classification of Headache Disorders III beta version diagnostic criteria. The Migraine Disability Assessment Scale (MIDAS), Beck Depression Inventory(BDI), Pittsburgh Sleep Quality Index (PSQI),and a visual analog scale (VAS) were used on patients before GON pulsed radiofrequency treatment and at post treatment months 1 and 3. Results:The median duration and number of migraine episodes in the post-interventional 1st month and 3rd month were significantly shorter and fewer compared with the pre intervention period (p\<0.001). In the comparison with the pre intervention values, all of the scoring concepts, namely the MIDAS, VAS, BDI, and PSQI, revealed a significant drop in the post intervention 1st and 3rd month (p\<0.001). Conclusion: In this study, we observed that ultrasound-guided GON pulsed radiofrequency therapy applied at the proximal (C2) level was a safe and effective treatment option.With GON pulsed radiofrequency, we observed a decrease in pain intensity, pain frequency, andduration of episodes, and an improvement in depression symptoms, migraine disability, and sleep disorder scores accompanying chronic migraine.

Conditions

Migraine; Headache Disorders, Primary

Keywords

migraine; ultrasound, greater occipital nerve(GON), radiofrequency

Outcome Measures

Primary Outcomes (2)

• GON pulsed radiofrequency therapy applied from the proximal level under ultrasound guidance is effective and safe.

  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.

  3 months

• GON pulsed radiofrequency therapy applied from the proximal level under ultrasound guidance provides positive effects on quality of life, depression and sleep.

  GON RF treatment provided significant improvement in the scores (BDI,MIDAS, VAS and PSQI) of all patients withmigraine in our study.

  3 months

Study Arms (1)

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.

Other: Ultrasound guided greater occipital nerve (GON) radiofrequency

Interventions

Ultrasound guided greater occipital nerve (GON) radiofrequency OTHER

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

Also known as: GON RF

Chronic refractory migraine patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Chronic refractory migraine patients

You may not qualify if:

• Other primer headache disorders, İntracranial lesion, Bleeding disorders.

Sponsors & Collaborators

• Tepecik Training and Research Hospital: lead

Study Sites (1)

Tepecik Training and Research Hospital

Izmir, 35000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders; Headache Disorders, Primary

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 20, 2022
• Study Start: September 15, 2020
• Primary Completion: September 15, 2021
• Study Completion: October 15, 2021
• Last Updated: February 4, 2022

Record last verified: 2022-01

Locations

TU (1)