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

NCT06458179 | Completed

• 1 other identifier: Occipital neuralgia
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Occipital Neuralgia

Keywords

headache; ultrasonography; greater occipital nerve; radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline VAS at 1,3, 6 and 12 months

Secondary Outcomes (1)

• Headache impact disability index (HIT-6)

  Change from Baseline VAS at 1,3, 6 and 12 months

Study Arms (1)

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

Interventions

Ultrasound-guided proximal greater occipital nerve radiofrequency ablation PROCEDURE

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.

Proximal greater occipital nerve radiofrequency ablation (RFA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients with unilateral primary occipital neuralgia

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin Training and Research Hospital: lead

Study Sites (1)

Mersin Training and Research Hospital

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: sponspor investigator

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 13, 2024
• Study Start: January 1, 2022
• Primary Completion: April 29, 2023
• Study Completion: April 30, 2023
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

TU (1)