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Ultrasound Guided Radiofrequency Ablation of Proximal Greater Occipital Nerve in Primary Occipital Neuralgia

Retrospective Cohort Study for One Year Follow-up: Ultrasound Guided Radiofrequency Ablation of Proximal Greater Occipital Nerve is Effective

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06458179
Acronym
PGON-RFA
Enrollment
18
Registered
2024-06-13
Start date
2022-01-01
Completion date
2023-04-30
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occipital Neuralgia

Keywords

headache, ultrasonography, greater occipital nerve, radiofrequency ablation

Brief 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). 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.

Interventions

PROCEDUREUltrasound-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.

Sponsors

Mersin Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
NRSChange from Baseline VAS at 1,3, 6 and 12 monthsNumerical 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.

Secondary

MeasureTime frameDescription
Headache impact disability index (HIT-6)Change from Baseline VAS at 1,3, 6 and 12 monthsThese 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026