AzTrials
AzTrials

MigraineNCT05199064

Efficacy of Greater Occipital Nerve Radiofrequency for Refractory Migraine Treatment

An observational study of Migraine and Headache Disorders, Primary, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Migraine, Headache Disorders, Primary
What is being tested?
Ultrasound guided greater occipital nerve (GON) radiofrequency
How many people
25 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Sep 2020to 15 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • Chronic refractory migraine patients

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Tepecik Training and Research Hospital

    Izmir, 35000

Other trials in Turkey (Türkiye)

About this study

Official title: Efficacy of Ultrasound Guided Greater Occipital Nerve Pulsed Radiofrequency Therapy in Chronic Refractory Migraine

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.

Read the 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

Being tested
Ultrasound guided greater occipital nerve (GON) radiofrequency
Keywords
migraine; ultrasound, greater occipital nerve(GON), radiofrequency
Medical subject headings
Migraine Disorders, Headache Disorders, Primary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound guided greater occipital nerve (GON) radiofrequencyOther

    Also called GON RF

    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

Study groups in NCT05199064
Study groupRoleWhat they receive
Chronic refractory migraine patients25 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.
Receives: Other: Ultrasound guided greater occipital nerve (GON) radiofrequency

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2022
  2. Study start15 Sep 2020
  3. Primary completion15 Sep 2021
  4. Study completion15 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05199064
Sponsor's protocol ID
Tepecik TRH
Status last verified
Jan 2022
First submitted
5 Jan 2022
Last updated
4 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine and Headache Disorders, Primary, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

GON pulsed radiofrequency therapy applied from the proximal level under ultrasound guidance is effective and safe. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in