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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05499689
Other study ID # Transcutaneous GON
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 22, 2021
Est. completion date August 22, 2023

Study information

Verified date February 2023
Source Diskapi Teaching and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the investigator is to compare the efficacy of greater occipital nerve block and transcutaneous pulsed radiofrequency treatment in migraine.


Description:

Migraine is the second most common primary headache. Greater occipital nerve (GON) block is an effective method in the treatment of migraine. Transcutaneous pulsed radiofrequency (RF) therapy is used in the treatment of pain. However, its use in headaches is not widespread yet. Investigator aimed to compare the efficacy of transcutaneous pulsed radiofrequency therapy applied through the GON trace and GON block therapy. A 60-patient study was designed. GON block was planned for 30 patients and transcutaneous pulsed RF was planned for 30 patients. The block will be applied once at the level of C2 vertebra with ultrasound.Transcutaneous pulsed RF will be applied twice, once a week, for 8 minutes.All patients will have pre-treatment migraine disability assessment score (MIDAS) scores filled. A headache diary will be provided to all patients. Frequency and severity of pain will be followed for 1 month. Pain intensity will be evaluated on the visual analog scale (VAS). Investigator aimed to evaluate the efficacy of transcutaneous pulsed RF therapy, which is a noninvasive method, in migraine.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date August 22, 2023
Est. primary completion date June 22, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Chronic Migraine Exclusion Criteria: - Other headaches will not accompany (tension-type headache, cluster...) - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine Hydrochloride
2.5 cc bupivacain injection will be administered by approaching the greater occipital nerve under ultrasound guidance.
Other:
Transcutaneous pulsed radiofrequency qurrent
Pulsed radiofrequency current will be applied through transcutaneous pads adhered over the greater occipital nerve trace on the nape.

Locations

Country Name City State
Turkey Diskapi Yildirim Beyazit Teaching and Research Hospital Ankara Altindg

Sponsors (1)

Lead Sponsor Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Migraine Disability Assessment Test The MIDAS questionnaire is an important part of a package of educational, investigative, and therapeutic measures, and could play a major role in improving the care of patients with migraine and other types of headache. Baseline
Secondary Visual analog scale (VAS) It is a scale that measures the severity of pain. Scored between ''0: no pain'' and ''10: worst pain'' . Baseline, Week 4
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