Migraine DisordersNCT05499689
Transcutaneous Pulsed Radiofrequency in Migraine
A study testing Bupivacaine Hydrochloride and Transcutaneous pulsed radiofrequency qurrent in people with Migraine Disorders, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the investigator is to compare the efficacy of greater occipital nerve block and transcutaneous pulsed radiofrequency treatment in migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Bupivacaine Hydrochloride and Transcutaneous pulsed radiofrequency qurrent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jun 2021to 22 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Migraine
Who cannot join
- Other headaches will not accompany (tension-type headache, cluster...)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazıt Teaching and Research Hospital
Ankara, Altındğ
About this study
Official title: Comparison of Transcutaneous Pulsed Radiofrequency Therapy and Greater Occipital Nerve Block Efficiency in Migraine Headache
The aim of the investigator is to compare the efficacy of greater occipital nerve block and transcutaneous pulsed radiofrequency treatment in migraine.
Read the 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.
- Conditions
- Migraine Disorders
- Being tested
- Bupivacaine Hydrochloride, Transcutaneous pulsed radiofrequency qurrent
- Keywords
- Transcutaneous pulsed radiofrequency, pulsed radiofrequency treatment, headache, GON block
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideDrug
2.5 cc bupivacain injection will be administered by approaching the greater occipital nerve under ultrasound guidance.
Transcutaneous pulsed radiofrequency qurrentOther
Pulsed radiofrequency current will be applied through transcutaneous pads adhered over the greater occipital nerve trace on the nape.
| Study group | Role | What they receive |
|---|---|---|
| GON block group | Active comparator | 30 patients who underwent greater occipital nerve block Receives: Drug: Bupivacaine Hydrochloride |
| Transcutaneous pulsed RF group | Active comparator | 30 patients who underwent greater occipital nerve pulsed radiofrequency Receives: Other: Transcutaneous pulsed radiofrequency qurrent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
Visual analog scale (VAS)
It is a scale that measures the severity of pain. Scored between ''0: no pain'' and ''10: worst pain'' .
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start22 Jun 2021
- Primary completion22 Jun 2023 (estimated)
- Study completion22 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- mehlika panpallı ateş, Study chair, Diskapi TRHömer taylan akkaya, Study director, Diskapi TRHHüseyin Alp Alptekin, Study chair, Diskapi TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499689
- Sponsor's protocol ID
- Transcutaneous GON
- Status last verified
- Feb 2023
- First submitted
- 11 Aug 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38147268
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Transcutaneous Pulsed Radiofrequency Therapy and Greater Occipital Nerve Block Efficiency in Migraine Headache
- ClinicalTrials.gov ID
- NCT05499689
- Acronym / sponsor ID
- Transcutaneous GON
- Conditions
- Migraine Disorders
- Keywords
- Transcutaneous pulsed radiofrequency, pulsed radiofrequency treatment, headache, GON block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 22 Jun 2023 (estimated)
- Study completion
- 22 Aug 2023 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GON block group | Active comparator | Drug: Bupivacaine Hydrochloride30 patients who underwent greater occipital nerve block |
| Transcutaneous pulsed RF group | Active comparator | Other: Transcutaneous pulsed radiofrequency qurrent30 patients who underwent greater occipital nerve pulsed radiofrequency |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic Migraine
Key exclusion criteria (2 listed)
- Other headaches will not accompany (tension-type headache, cluster...)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine Hydrochloride2.5 cc bupivacain injection will be administered by approaching the greater occipital nerve under ultrasound guidance. | Drug | GON block group |
| Transcutaneous pulsed radiofrequency qurrentPulsed radiofrequency current will be applied through transcutaneous pads adhered over the greater occipital nerve trace on the nape. | Other | Transcutaneous pulsed RF group |
Primary outcome
The Migraine Disability Assessment Test
Time frame: 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.
1 secondary outcome
Visual analog scale (VAS)
Time frame: Baseline, Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Derived from this study: PubMed 38147268Perdecioglu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mehlika panpallı ateş study chair
Diskapi TRH
ömer taylan akkaya study director
Diskapi TRH
Hüseyin Alp Alptekin study chair
Diskapi TRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine Hydrochloride and Transcutaneous pulsed radiofrequency qurrent in people with Migraine Disorders, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Migraine Disability Assessment Test (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05499689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.