Transcutaneous Pulsed Radiofrequency in Migraine

Sponsor

Diskapi Teaching and Research Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05499689

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Migraine Disorders	Drug: Bupivacaine Hydrochloride Other: Transcutaneous pulsed radiofrequency qurrent	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison of Transcutaneous Pulsed Radiofrequency Therapy and Greater Occipital Nerve Block Efficiency in Migraine Headache

Actual Study Start Date :

Jun 22, 2021

Anticipated Primary Completion Date :

Dec 22, 2022

Anticipated Study Completion Date :

Jun 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: GON block group 30 patients who underwent greater occipital nerve block	Drug: Bupivacaine Hydrochloride 2.5 cc bupivacain injection will be administered by approaching the greater occipital nerve under ultrasound guidance.
Active Comparator: Transcutaneous pulsed RF group 30 patients who underwent greater occipital nerve pulsed radiofrequency	Other: Transcutaneous pulsed radiofrequency qurrent Pulsed radiofrequency current will be applied through transcutaneous pads adhered over the greater occipital nerve trace on the nape.

Arm

Intervention/Treatment

Active Comparator: GON block group

30 patients who underwent greater occipital nerve block

Drug: Bupivacaine Hydrochloride

2.5 cc bupivacain injection will be administered by approaching the greater occipital nerve under ultrasound guidance.

Active Comparator: Transcutaneous pulsed RF group

30 patients who underwent greater occipital nerve pulsed radiofrequency

Other: Transcutaneous pulsed radiofrequency qurrent

Pulsed radiofrequency current will be applied through transcutaneous pads adhered over the greater occipital nerve trace on the nape.

Outcome Measures

Primary Outcome Measures

The Migraine Disability Assessment Test [Baseline]
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.

Secondary Outcome Measures

Visual analog scale (VAS) [Baseline, Week 4]
It is a scale that measures the severity of pain. Scored between ''0: no pain'' and ''10: worst pain'' .

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Chronic Migraine

Exclusion Criteria:

Other headaches will not accompany (tension-type headache, cluster...)
Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diskapi Yildirim Beyazıt Teaching and Research Hospital	Ankara	Altındğ	Turkey

Sponsors and Collaborators

Diskapi Teaching and Research Hospital

Investigators

Study Chair: mehlika panpallı ateş, Diskapi TRH
Study Director: ömer taylan akkaya, Diskapi TRH
Study Chair: Hüseyin Alp Alptekin, Diskapi TRH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Damla Yürük, Director, medical doctor, Diskapi Teaching and Research Hospital

ClinicalTrials.gov Identifier:

NCT05499689

Other Study ID Numbers:

Transcutaneous GON

First Posted:

Aug 12, 2022

Last Update Posted:

Aug 16, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Damla Yürük, Director, medical doctor, Diskapi Teaching and Research Hospital

Transcutaneous pulsed radiofrequency

pulsed radiofrequency treatment

headache

GON block

Additional relevant MeSH terms:

Migraine Disorders

Bupivacaine

Study Results

No Results Posted as of Aug 16, 2022