Ultrasound Guided Radiofrequency Ablation of Proximal Greater Occipital Nerve in Primary Occipital Neuralgia (PGON-RFA)

November 19, 2024 updated by: Suna Aşkın Turan, Mersin Training and Research Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Mersin, Turkey
        • Mersin Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male and female patients who underwent ultrasound-guided greater occipital nerve radiofrequency ablation for unilateal primary occipital neuralgia

Description

Inclusion Criteria:

  • Patients with unilateral primary occipital neuralgia

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Ultrasound-guided proximal greater occipital nerve radiofrequency ablation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline VAS at 1,3, 6 and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Headache impact disability index (HIT-6)
Time Frame: Change from Baseline VAS at 1,3, 6 and 12 months
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.
Change from Baseline VAS at 1,3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mersin Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Occipital neuralgia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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