Occipital NeuralgiaPGON-RFANCT06458179
Ultrasound Guided Radiofrequency Ablation of Proximal Greater Occipital Nerve in Primary Occipital Neuralgia
An observational study of Occipital Neuralgia, run by Mersin Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The International Headache Society (IHS) defines occipital neuralgia, as a unilateral or bilateral paroxysmal, shooting, or stabbing pain in the posterior region of the scalp, in the distribution of the greater occipital nerve (GON), lesser occipital nerve (LON), or third occipital nerve (TON). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occipital Neuralgia
- What is being tested?
- Ultrasound-guided proximal greater occipital nerve radiofrequency ablation
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 Apr 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients who underwent ultrasound-guided greater occipital nerve radiofrequency ablation for unilateal primary occipital neuralgia
Who may be able to join
- Patients with unilateral primary occipital neuralgia
Who cannot join
- Patients lacking documentation or inadequate follow-up
- Patients whom taking analgesic medication during the follow-up period
- Bilateral occipital neuralgia
- Secondary occipital neuralgia (e.g., cervical radiculopathy, infection, tumor, vascular compression of nerve, musculoskeletal diseases like C1-2 arthrosis)
- Other primary headaches
- Dermatitis or skin infections
- Pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Cohort Study for One Year Follow-up: Ultrasound Guided Radiofrequency Ablation of Proximal Greater Occipital Nerve is Effective
The International Headache Society (IHS) defines occipital neuralgia, as a unilateral or bilateral paroxysmal, shooting, or stabbing pain in the posterior region of the scalp, in the distribution of the greater occipital nerve (GON), lesser occipital nerve (LON), or third occipital nerve (TON). The condition is occasionally accompanied by diminished sensation or dysesthesia in the affected area and is frequently associated with tenderness over the involved nerves. The majority of cases with occipital neuralgia are idiopathic, with no clearly defined anatomical cause. First, conservative treatment approaches including medication and physical therapy are frequently used. When conservative measures fail to alleviate occipital neuralgia, interventional treatments such as local occipital nerve anesthetic and corticosteroid infiltration, botulinum toxin A injection, occipital nerve subcutaneous neurostimulation or occipital nerve radifrequency treatment may be used.
Read the detailed description
Radiofrequency ablation (RFA) is a thermal ablative procedure commonly used to treat chronic neurogenic pain by targeting peripheral nerves or dorsal root ganglion by destructing the tissue at a temperature ranging beteen 60-80 C. The pain is interrupted by destructing the nerve with Wallerian dejeneration. The pain interruption period is longer and stronger than pulsed radiofrequency. GON is a pure sensory nerve, RFA may be an alternative therapy option for occipital neuralgia. By ultrasound (US) guidance, at C2 level , GON lies between semispinalis capitis muscle and inferior oblique muscle. The GON is well identified here and can be easily targeted rather than trying to identify the terminal subcutaneous branches at the nuchal line. Diagnostic blockade was administered to patients who did not respond to conventional therapy. If the response to diagnostic blockade was greater than 50%, RFA was instituted one week later. Patients' headache intensity was measured using the Numeric Rating Scale-11 Pain Score (NRS) at each appointment (pre-intervention, 1-3-6, and 12 months post-intervention). At each appointment, an evaluation of headache disability was conducted using the Headache Impact Test (Hit-6) and the number of headache days per month. The efficacy of the treatment was defined as NRS<4 at the twelveth month. During the initial evaluation, patients' demographic details and headache symptoms were thoroughly questioned. In accordance with the Turkish National Headache and Pain Research Association's recommendation, patients were asked to keep up headache diaries for the duration of the treatment and all subsequent appointments. The headache intensity, headache disability and the number of headache days in a month, as well as the use of rescue medication, including NSAIDs and paracethamol, were determined from the diaries and discussed with the patient at each session.
- Conditions
- Occipital Neuralgia
- Being tested
- Ultrasound-guided proximal greater occipital nerve radiofrequency ablation
- Keywords
- headache, ultrasonography, greater occipital nerve, radiofrequency ablation
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided proximal greater occipital nerve radiofrequency ablationProcedure or surgery
In the prone position with the head slightly flexed and the US probe was placed in the neck transversely and then was located the bifid spinous process of C2 and the probe was lateralized (toward the affected side). At this level, the GON is located above the obliquus capitis inferior muscle and deeper than the semispinalis capitis muscle. The in-plane approach from medial to lateral was employed to treat the nerve with a 21 G 5-mm active tip radiofrequency needle. Sensory stimulation was administered at 50 Hz for 1 ms to induce paresthesia, pain, or irritation. A motor stimulus was applied at 2 Hz for 1 ms and up to 2 volts to see if fasciculation was absent. Then 1 mL of 2% lidocaine was administered through the RF cannulas to alleviate procedure related pain. Conventional RFA was conducted for 60 seconds at a temperature of 60 degrees. Following the procedure, 2 mg of dexamethasone was administered per lesion site.
| Study group | Role | What they receive |
|---|---|---|
| Proximal greater occipital nerve radiofrequency ablation (RFA) | Between January 1, 2022 and April 30, 2023, all patients diagnosed with primary unilateral occipital neuralgia who underwent US-guided diagnostic occipital nerve block and subsequent RFA of the PGON and were followed up for a minimum of one year were identified and included in the database. Patients lacking documentation or inadequate follow-up were excluded. Excluded from the study were patients with bilateral ON, secondary ON, other primary headaches, dermatitis or skin infections, and pacemakers. Based on clinical history and neurolgical examination (including Tinel's test), ON was diagnosed. Receives: Procedure: Ultrasound-guided proximal greater occipital nerve radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
Numerical rating scale (NRS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control.
Measured: Change from Baseline VAS at 1,3, 6 and 12 months
Secondary outcomes (1)
Headache impact disability index (HIT-6)
These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent. Scores can be interpreted using four groupings that indicate the severity of headache impact on the patient's life.
Measured: Change from Baseline VAS at 1,3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jan 2022
- Primary completion29 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occipital NeuralgiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Suna Aşkın Turan, Mersin Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458179
- Sponsor's protocol ID
- Occipital neuralgia
- Acronym
- PGON-RFA
- Status last verified
- Nov 2024
- First submitted
- 9 Jun 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cohort Study for One Year Follow-up: Ultrasound Guided Radiofrequency Ablation of Proximal Greater Occipital Nerve is Effective
- ClinicalTrials.gov ID
- NCT06458179
- Acronym / sponsor ID
- PGON-RFA / Occipital neuralgia
- Conditions
- Occipital Neuralgia
- Keywords
- headache, ultrasonography, greater occipital nerve, radiofrequency ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mersin Training and Research HospitalOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 29 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 13 Jun 2024 (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 International Headache Society (IHS) defines occipital neuralgia, as a unilateral or bilateral paroxysmal, shooting, or stabbing pain in the posterior region of the scalp, in the distribution of the greater occipital nerve (GON), lesser occipital nerve (LON), or third occipital nerve (TON). The condition is occasionally accompanied by diminished sensation or dysesthesia in the affected area and is frequently associated with tenderness over the involved nerves. The majority of cases with occipital neuralgia are idiopathic, with no clearly defined anatomical cause. First, conservative treatment approaches including medication and physical therapy are frequently used. When conservative measures fail to alleviate occipital neuralgia, interventional treatments such as local occipital nerve anesthetic and corticosteroid infiltration, botulinum toxin A injection, occipital nerve subcutaneous neurostimulation or occipital nerve radifrequency treatment may be used.
Detailed description
Radiofrequency ablation (RFA) is a thermal ablative procedure commonly used to treat chronic neurogenic pain by targeting peripheral nerves or dorsal root ganglion by destructing the tissue at a temperature ranging beteen 60-80 C. The pain is interrupted by destructing the nerve with Wallerian dejeneration. The pain interruption period is longer and stronger than pulsed radiofrequency. GON is a pure sensory nerve, RFA may be an alternative therapy option for occipital neuralgia. By ultrasound (US) guidance, at C2 level , GON lies between semispinalis capitis muscle and inferior oblique muscle. The GON is well identified here and can be easily targeted rather than trying to identify the terminal subcutaneous branches at the nuchal line. Diagnostic blockade was administered to patients who did not respond to conventional therapy. If the response to diagnostic blockade was greater than 50%, RFA was instituted one week later. Patients' headache intensity was measured using the Numeric Rating Scale-11 Pain Score (NRS) at each appointment (pre-intervention, 1-3-6, and 12 months post-intervention). At each appointment, an evaluation of headache disability was conducted using the Headache Impact Test (Hit-6) and the number of headache days per month. The efficacy of the treatment was defined as NRS<4 at the twelveth month. During the initial evaluation, patients' demographic details and headache symptoms were thoroughly questioned. In accordance with the Turkish National Headache and Pain Research Association's recommendation, patients were asked to keep up headache diaries for the duration of the treatment and all subsequent appointments. The headache intensity, headache disability and the number of headache days in a month, as well as the use of rescue medication, including NSAIDs and paracethamol, were determined from the diaries and discussed with the patient at each session.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proximal greater occipital nerve radiofrequency ablation (RFA) | – | Procedure: Ultrasound-guided proximal greater occipital nerve radiofrequency ablationBetween January 1, 2022 and April 30, 2023, all patients diagnosed with primary unilateral occipital neuralgia who underwent US-guided diagnostic occipital nerve block and subsequent RFA of the PGON and were followed up for a minimum of one year were identified and included in the database. Patients lacking documentation or inadequate follow-up were excluded. Excluded from the study were patients with bilateral ON, secondary ON, other primary headaches, dermatitis or skin infections, and pacemakers. Based on clinical history and neurolgical examination (including Tinel's test), ON was diagnosed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients who underwent ultrasound-guided greater occipital nerve radiofrequency ablation for unilateal primary occipital neuralgia
Key inclusion criteria (1 listed)
- Patients with unilateral primary occipital neuralgia
Key exclusion criteria (7 listed)
- Patients lacking documentation or inadequate follow-up
- Patients whom taking analgesic medication during the follow-up period
- Bilateral occipital neuralgia
- Secondary occipital neuralgia (e.g., cervical radiculopathy, infection, tumor, vascular compression of nerve, musculoskeletal diseases like C1-2 arthrosis)
- Other primary headaches
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 |
|---|---|---|
| Ultrasound-guided proximal greater occipital nerve radiofrequency ablationIn the prone position with the head slightly flexed and the US probe was placed in the neck transversely and then was located the bifid spinous process of C2 and the probe was lateralized (toward the affected side). At this level, the GON is located above the obliquus capitis inferior muscle and deeper than the semispinalis capitis muscle. The in-plane approach from medial to lateral was employed to treat the nerve with a 21 G 5-mm active tip radiofrequency needle. Sensory stimulation was administered at 50 Hz for 1 ms to induce paresthesia, pain, or irritation. A motor stimulus was applied at 2 Hz for 1 ms and up to 2 volts to see if fasciculation was absent. Then 1 mL of 2% lidocaine was administered through the RF cannulas to alleviate procedure related pain. Conventional RFA was conducted for 60 seconds at a temperature of 60 degrees. Following the procedure, 2 mg of dexamethasone was administered per lesion site. | Procedure or surgery | Proximal greater occipital nerve radiofrequency ablation (RFA) |
Primary outcome
NRS
Time frame: Change from Baseline VAS at 1,3, 6 and 12 months
Numerical rating scale (NRS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control.
1 secondary outcome
Headache impact disability index (HIT-6)
Time frame: Change from Baseline VAS at 1,3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Occipital Neuralgia
RecruitingObservational study
Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain
Chronic Pain, PERIPHERAL NEUROPATHY
Active, not recruiting
The MONARCH Case Series Study: SPRINT® Peripheral Nerve Stimulation for the Treatment of Head Pain
Cervicogenic Headache, Occipital Neuralgia
Recruiting
Efficacy of Adding Greater Occipital Nerve Block to Trigger Point Injection in Patients With Neck Pain
Neck Pain, Myofacial Pain Syndrome
Not yet recruitingPhase 3
0.5% Bupivacaine Lower Cervical Intramuscular Injection vs IV Medications for Headache Treatment
Headache, Migraine
Recruiting
Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve
Nerve Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occipital Neuralgia, run by Mersin Training 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 7 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: finished, as of the sponsor's last update on 21 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
NRS (time frame: Change from Baseline VAS at 1,3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024.