Transcutaneous Pulsed Radiofrequency in Migraine

NCT ID: NCT05499689

Last Updated: 2023-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-22

Study Completion Date

2023-08-22

Brief Summary

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

Detailed Description

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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.

Conditions

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Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GON block group

30 patients who underwent greater occipital nerve block

Group Type ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type DRUG

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

Transcutaneous pulsed RF group

30 patients who underwent greater occipital nerve pulsed radiofrequency

Group Type ACTIVE_COMPARATOR

Transcutaneous pulsed radiofrequency qurrent

Intervention Type OTHER

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

Interventions

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Bupivacaine Hydrochloride

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

Intervention Type DRUG

Transcutaneous pulsed radiofrequency qurrent

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Chronic Migraine

Exclusion Criteria

* Other headaches will not accompany (tension-type headache, cluster...)
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Damla Yürük

Director, medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mehlika panpallı ateş

Role: STUDY_CHAIR

Diskapi TRH

ömer taylan akkaya

Role: STUDY_DIRECTOR

Diskapi TRH

Hüseyin Alp Alptekin

Role: STUDY_CHAIR

Diskapi TRH

Locations

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Diskapi Yildirim Beyazıt Teaching and Research Hospital

Ankara, Altındğ, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Perdecioglu GRG, Ates MP, Yuruk D, Can E, Yildiz G, Akkaya OT. A new neuromodulation method in chronic migraine; non-invasive pulsed radiofrequency, a single-blinded, randomised, controlled trial. Ir J Med Sci. 2024 Jun;193(3):1487-1493. doi: 10.1007/s11845-023-03598-x. Epub 2023 Dec 26.

Reference Type DERIVED
PMID: 38147268 (View on PubMed)

Other Identifiers

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Transcutaneous GON

Identifier Type: -

Identifier Source: org_study_id

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