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Transcutaneous Pulsed Radiofrequency in Migraine

Primary Purpose

Migraine Disorders

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride
Transcutaneous pulsed radiofrequency qurrent
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring Transcutaneous pulsed radiofrequency, pulsed radiofrequency treatment, headache, GON block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic Migraine

Exclusion Criteria:

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

Sites / Locations

  • Diskapi Yildirim Beyazıt Teaching and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

GON block group

Transcutaneous pulsed RF group

Arm Description

30 patients who underwent greater occipital nerve block

30 patients who underwent greater occipital nerve pulsed radiofrequency

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 11, 2022
Last Updated
February 2, 2023
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05499689
Brief Title
Transcutaneous Pulsed Radiofrequency in Migraine
Official Title
Comparison of Transcutaneous Pulsed Radiofrequency Therapy and Greater Occipital Nerve Block Efficiency in Migraine Headache
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
June 22, 2023 (Anticipated)
Study Completion Date
August 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
Transcutaneous pulsed radiofrequency, pulsed radiofrequency treatment, headache, GON block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GON block group
Arm Type
Active Comparator
Arm Description
30 patients who underwent greater occipital nerve block
Arm Title
Transcutaneous pulsed RF group
Arm Type
Active Comparator
Arm Description
30 patients who underwent greater occipital nerve pulsed radiofrequency
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
2.5 cc bupivacain injection will be administered by approaching the greater occipital nerve under ultrasound guidance.
Intervention Type
Other
Intervention Name(s)
Transcutaneous pulsed radiofrequency qurrent
Intervention Description
Pulsed radiofrequency current will be applied through transcutaneous pads adhered over the greater occipital nerve trace on the nape.
Primary Outcome Measure Information:
Title
The Migraine Disability Assessment Test
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS)
Description
It is a scale that measures the severity of pain. Scored between ''0: no pain'' and ''10: worst pain'' .
Time Frame
Baseline, Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic Migraine Exclusion Criteria: Other headaches will not accompany (tension-type headache, cluster...) Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mehlika panpallı ateş
Organizational Affiliation
Diskapi TRH
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
ömer taylan akkaya
Organizational Affiliation
Diskapi TRH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hüseyin Alp Alptekin
Organizational Affiliation
Diskapi TRH
Official's Role
Study Chair
Facility Information:
Facility Name
Diskapi Yildirim Beyazıt Teaching and Research Hospital
City
Ankara
State/Province
Altındğ
Country
Turkey

12. IPD Sharing Statement

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Transcutaneous Pulsed Radiofrequency in Migraine

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