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Pak, R.J.; Ku, J.B.; Abd-Elsayed, A. Neuromodulation for Craniofacial Pain and Headaches. Encyclopedia. Available online: (accessed on 21 June 2024).
Pak RJ, Ku JB, Abd-Elsayed A. Neuromodulation for Craniofacial Pain and Headaches. Encyclopedia. Available at: Accessed June 21, 2024.
Pak, Ray J., Jun B. Ku, Alaa Abd-Elsayed. "Neuromodulation for Craniofacial Pain and Headaches" Encyclopedia, (accessed June 21, 2024).
Pak, R.J., Ku, J.B., & Abd-Elsayed, A. (2024, January 03). Neuromodulation for Craniofacial Pain and Headaches. In Encyclopedia.
Pak, Ray J., et al. "Neuromodulation for Craniofacial Pain and Headaches." Encyclopedia. Web. 03 January, 2024.
Neuromodulation for Craniofacial Pain and Headaches

Headaches and facial pain are highly prevalent diseases but are often difficult to treat. Though there have been significant advances in medical management, many continue to suffer from refractory pain. Neuromodulation has been gaining interest for its therapeutic purposes in many chronic pain conditions, including headaches and facial pain. There are many potential targets of neuromodulation for headache and facial pain, and some have more robust evidence in favor of their use than others.

headache facial pain stimulation neuralgia migraine cluster neuromodulation

1. Introduction

Headaches are a common complaint, with an estimated lifetime prevalence of 95% and a general prevalence of 48.9% [1]. They are classified based on their characteristics as outlined in the International Classification of Headache Disorders (ICHD); primary headaches are classified as migraine, tension-type, trigeminal autonomic cephalgia (e.g., cluster headache), or other primary headache disorders. Secondary headaches or other facial pain have a larger differential, including trauma to the head and/or neck, cranial or cervical vascular disease, nonvascular intracranial disorders, substance use or withdrawal, infection, a disorder of homeostasis, other structural disorder, psychiatric disorders, or other. As one might expect from the terminology, primary headaches have no known underlying cause, while secondary headaches result from another condition that may cause traction or inflammation of pain-generating structures, such as the trigeminal nerve [2]. Primary headaches constitute nearly 98% of all headaches, but secondary headaches are important to recognize as they may often be a consequence of life-threatening disorders [1].
Facial pain may be classified according to reported symptoms and history. The differential diagnosis is broad, including pain of musculoskeletal origin, dental pain, primary headache, neuralgia, neuropathy, etc. [3][4][5][6][7].
Though most headaches may not be life-threatening, they are still a source of significant discomfort for patients, and so treatment is an important consideration for physicians. Primary headache management varies depending on type but generally includes some type of abortive medication, as well as preventive if frequency is high enough. For example, in the case of migraines, a patient may use acetaminophen, an NSAID, or triptan (or some combination thereof) as an abortive and take a daily amitriptyline for prevention. There are a few procedures that are also used for headaches. OnabotulinumtoxinA, commonly known as “Botox” and nerve blocks (specifically of the greater occipital nerve) are also treatment options for migraine prophylaxis [1][2].
Neuromodulation has been gaining significant interest and popularity in the treatment of various chronic pain disorders, including neuropathic and back pain. It refers to a technique that uses pulsed electrical energy near a nerve or spinal cord, using leads implanted into a nearby space. This technique is based on the gate control theory of pain, initially proposed by Melzac and Wall in 1965. The conventional understanding of how neuromodulation works to reduce pain is that by stimulating larger A-beta fibers, pain signals carried by smaller C- and A-delta fibers may be interrupted [8][9]. It is stated that the first reported clinical application of spinal cord stimulation was two years later, but its popularity has been increasing significantly since [10]. The first reported case in the management of intractable headaches was in the late 1990s [11].

2. Neuromodulation for Craniofacial Pain and Headaches

The results of neurostimulation in the context of headaches and facial pain are promising, especially in patients with pain refractory to other treatment modalities. In addition, given the significant suffering that patients with these conditions may deal with, neuromodulation is a way to provide significant relief to many patients who suffer from these conditions. The use of neurostimulation may also help reduce or eliminate the need for preventive medications in patients as well as improve disability, quality of life, mood, and sleep. However, many of the studies published as of the writing of this entry are uncontrolled studies or case reports, which raise concerns for placebo effect and bias. This is in part due to practical considerations, such as the difficulty in blinding when many treatments elicit paresthesia and the relative rarity of some headache disorders, which was recognized by several authors. The crossover study design does mitigate this somewhat and, for this reason, many trials have exploited it in their studies.
There is also a question of the long-term efficacy of neuromodulation. Many studies do show promise in some patients up to a few months out from implantation, but some do appear to experience the recurrence of headaches after some time. However, this may be secondary to technical failures, as some studies found that effective stimulation was not being delivered at the time of follow-up. Interestingly, there appear to be several patients reported in the cited studies who had had the exact opposite and found that they were able to explant permanent stimulators due to significant pain relief. A summary of cited studied are provided in Table 1.
Table 1. Summary of cited articles categorized by targeted nerves.
In 2013, the European Headache Federation released a position on the use of neuromodulation for chronic headaches. Based on the available evidence at the time, it had recommended neurostimulation only in cases of chronic, medically intractable headaches. In the treatment of cCH, it recommended SPG or ONS prior to other forms of neurostimulation, such as DBS and in the management of CM, it stated that ONS may be acceptable. It did acknowledge that RCTs were scarce and that further trials may change the position on their use [96]. In 2021, the American Headache Society also stated that patients with intractable migraines or those with poor tolerability or contraindications with medications should be considered for a trial with FDA-approved neuromodulatory devices. For preventive treatment, they stated that all patients should be considered for a trial as an adjunct to the existing treatment plans [97].
A meta-analysis conducted in 2022 analyzed 45 studies studying preemptive treatments for refractory cCH, most focusing on neuromodulation. Consistent with the European Headache Federation’s recommendation years prior, the authors note that ONS appeared to be promising for the treatment of cCH. They also noted that DBS showed promise but had more heterogeneous results and a higher risk of complications [98]. Another meta-analysis analyzing 38 articles focused on acute or preventive treatment of migraines also noted the efficacy of ONS in terms of preventive migraine treatment [99].

3. Complications

Taking the cited studies into consideration, the most common complications are hardware-related, of which the majority are lead migration or battery depletion, but also include the malfunction of the electrodes. Though not as common as hardware complications, biologic events, commonly pain at the site of the implantable pulse generator (IPG) site or infections can also occur [14][16][17][20][21][24][25][29][30][31][32][34][35][37][38][39][41][81].
A retrospective analysis of a prospective, multicenter, double-blind controlled study on ONS for the management of chronic migraine aimed to analyze adverse event incidence rate’s relationship with device characteristics, surgical techniques, and IPG placement was carried out. The researchers noted that IPG pocket locations closer to the lead and more experienced implanters were associated with lower complication rates [95].


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