Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05199064 |
| Other study ID # |
Tepecik TRH |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2020 |
| Est. completion date |
October 15, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Tepecik Training and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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
