More than 30,000,000 Americans (18 percent of females and 6 percent of males) suffer from migraine headaches that often interfere with their job performance and interpersonal relationships.1–4 It is estimated that about one in every four households has someone who suffers from this condition.1 The prevalence and disabling nature of migraine headache make it a topic of interest to many, yet the condition remains largely underdiagnosed and undertreated.1 Furthermore, approximately one-third of migraine sufferers are not helped by standard therapies.5 The preventive and abortive pharmaceutical agents have associated adverse effects and are often very costly. Migraine headaches present an enormous economic burden to the individual sufferer and society in general due to missed work (a collective 112 million workdays per year) and loss of productivity totaling $14 billion annually in the United States.6 The total annual costs associated with migraine headache and its treatment total $13 billion to $17 billion annually, with the cost of medications for migraine headache alone accounting for $1.5 billion.7,8
The senior author (B.G.) has developed surgical techniques to deactivate migraine headache trigger sites. The research team has been investigating its efficacy over the last 10 years.9–12 Our retrospective,9 pilot prospective,10 and anatomical studies13–16 have all provided a foundation for this more comprehensive investigation to assess the effectiveness of this technique over a 5-year follow-up period. Our in-depth, previously published study of the surgical treatment of the four most common migraine trigger sites11 reported the outcome of the treatment at 1-year follow-up and compared the treatment group with controls who did not undergo surgery. The efficacy of this treatment was further documented with our single trigger site study, which incorporated a sham surgery control group.12 Other research groups have also demonstrated positive results with the surgical treatment of migraine headache.17–19 The purpose of this prospective study was to investigate the 5-year outcome in patients who underwent surgical treatment of migraine headache in one to four common trigger sites.
PATIENTS AND METHODS
Institutional review board approval was obtained from two separate institutions. The recruited volunteers were examined by the neurologist (J.S.K.) of the research team to ensure the diagnosis of migraine headache in accordance with the guidelines established by the International Headache Society. A total of 125 volunteers met the initial criteria. Patients underwent detailed evaluation to identify their trigger sites. They were asked about the most common focal site of onset of their migraine headache (migraine trigger sites). These trigger sites were palpated to detect any tenderness. For the nasal trigger site, examination of the internal nose was undertaken to observe the septum and the inferior turbinates; if applicable, the presence of enlarged turbinates and the type of septal deviation were documented. The observed intranasal pathology was confirmed with a computed tomography scan. Of the 125 patients diagnosed with migraine headache, 100 were randomly assigned to the treatment group and 25 served as controls. This control group sample size was selected by the biostatistician based on the results of the previous studies. Patients in the treatment group received injection of botulinum toxin A (Botox; Allergan, Irvine, Calif.) into three of the four trigger sites (frontal, temporal, and occipital) in a logical, stepwise manner; the most prominent site was injected first to provide confirmation. A total of up to four trigger points were identified in a variety of combinations for each patient, based on the constellation of symptoms, physical examination, and patient response to botulinum toxin A. Initially, the 25 control patients were injected with 0.5 ml of saline. After 1 year, the control group had the option to undergo surgical treatment. Of the 19 control group patients who completed the 1-year follow-up, 17 underwent identification and deactivation of their trigger sites.
All patients enrolled in the study were asked to complete the Medical Outcomes Study 36-Item Short Form Health Survey, Migraine-Specific Quality of Life, and Migraine Disability Assessment questionnaires before treatment and at the postoperative follow-up visits at 1 and 5 years. In addition, all patients continued to maintain a diary documenting the frequency (migraines per month), intensity (rated on a visual analogue scale from 0 to 10, with 10 being the most severe), and duration (in days) of any migraine headache experienced, associated symptoms, and possible triggers for 5 years. The recorded information for each visit also included calculation of a migraine index using the following formula: (intensity × frequency × duration).
Based on the identified trigger sites, surgery included any one of the following as a single procedure or in combination (in the same setting): removal of the glabellar muscle group, including the corrugator supercilii, depressor supercilii, and the lateral portion of the procerus muscles to decompress the supraorbital and supratrochlear nerves for the frontal trigger site (trigger site I); avulsion of a small portion of the zygomaticotemporal branch of the trigeminal nerve for the temporal trigger site (trigger site II); septoplasty and turbinectomy for the intranasal trigger site (trigger site III); and removal of a small segment of the semispinalis capitis muscle and shielding of the nerve with a subcutaneous flap to fully decompress the greater occipital nerve for the occipital trigger site (trigger site IV). For a detailed description of these procedures, refer to our previously published reports.10–12,20,21
Statistix Version 8 (Analystical Software, Inc., Tallahassee, Fla.), and StatView Version 5 (SAS Institute, Inc., Cary, N.C.) were used for statistical analysis of the data. Descriptive statistics were computed for all variables. A migraine headache index was calculated by multiplying together the frequency, intensity, and duration of migraine headache, and this was compared with the baseline migraine headache index. Two-tailed paired t tests were used to compare the mean frequency, intensity, and duration of migraine headaches and the migraine headache index measured before surgery (baseline) and at the last visit (60 months postoperatively). Repeated-measures analysis of variance was used to compare the mean frequency, intensity, and duration of migraines over time (0, 3, 6, 9, 12, 15, 18, 21, 24, 36, 48, and 60 months). If necessary, adjustments for multiple comparisons were made through Bonferroni correction. Chi-square analyses were performed to test for a relationship between categorical variables such as surgical sites and patients' improvement status. A p value less than 0.05 was considered significant. Reduction of at least 50 percent in migraine headache frequency, intensity, and/or duration compared with baseline values was used to define significant improvement.
Of the original 100 patients randomized to the treatment group, 91 had successful detection and confirmation of the trigger sites and underwent surgery, 89 were followed for 1 year,11 and 79 completed follow-up requirements for the entire 5-year period. There were 73 women and six men in the study. Their mean age was 43.6 years (range, 21 to 63 years). Fifty-nine patients experienced migraine headache without aura, 14 experienced migraine headache with aura, and six experienced migraine headache with and without aura. Of these 79 patients, 10 who underwent deactivation of additional (different) trigger sites during the 5-year follow-up period to provide them additional relief were not included in the final analysis to avoid extra confounding factors affecting the results. All 10 of these patients had already observed significant improvement (at least 50 percent reduction) before the second procedure. Of the remaining 69 patients, six had surgery on one trigger site, 15 underwent surgery on two trigger sites, 30 were subject of surgery on three trigger sites, and 18 underwent surgery on all four trigger sites (Table 1).
Outcome at 5 Years Compared with Baseline
The mean change from baseline in the frequency, intensity, and duration of migraine headache, as well as the average migraine headache index, at the 5-year follow-up is listed in Table 2. When compared with the baseline values, all measured variables improved significantly at 12 months, and this improvement was maintained at 60 months (p < 0.0001). The mean migraine frequency was 10.9 ± 7.46 at baseline compared with 4.0 ± 5.34 at 60 months (p < 0.0001). The mean migraine intensity was 8.5 ± 1.23 at baseline compared with 4.5 ± 3.18 at 60 months (p < 0.0001). The mean migraine duration was 1.4 ± 1.40 days at baseline compared with 0.31 ± 0.87 days at 60 months (p < 0.0001). Finally, the mean migraine headache index was 90.3 ± 80.10 at baseline compared with 11.4 ± 29.92 at 60 months (p < 0.0001).
Overall Surgical Outcome
Based on the criteria of at least 50 percent reduction in baseline migraine frequency, intensity, or duration, 61 of the 69 patients (88 percent) in the treatment group had benefited from surgery and have maintained an overall improvement. Twenty (29 percent) reported elimination of migraines, and 41 (59 percent) experienced a significant decrease. When we include the 10 patients who had undergone surgery in additional trigger sites during the follow-up period, 71 of 79 (90 percent) maintained the initial positive response to the surgery, with 22 (28 percent) experiencing elimination of migraines and 49 (62 percent) experiencing a significant decrease. There was no statistically significant difference in the final outcome with or without the inclusion of these 10 patients.
Analysis by Trigger Site
Considering specific trigger sites, 64 of 69 patients (93 percent) had a frontal migraine headache trigger site, 57 of 69 (83 percent) had a temporal migraine headache trigger site, 52 of 69 (75 percent) had an intranasal migraine headache trigger site, and 25 of 69 (36 percent) had an occipital migraine headache trigger site either in isolation or in conjunction with other trigger sites.
The surgical complications and their frequency are listed in Table 3. At 5 years, no patients had persistent intense itching or uneven brow movement. Twenty patients reported very occasional itching. Hair thinning at the site of the endoscopic incision was observed in three patients. Two patients reported hypersensitivity, two patients experienced hyposensitivity along the course of the supraorbital or supratrochlear nerves, and two patients reported numbness in the same areas at the 5-year follow-up. Three patients reported some mild occipital stiffness or weakness. One patient had injury to the temporal branch of the facial nerve which recovered completely.
This study was designed to assess the long-term success of surgical deactivation of migraine headache trigger points. The 5-year follow-up data reported here provide strong evidence that surgical deactivation of one or more trigger sites can successfully eliminate or reduce the frequency, duration, and intensity of migraine headache, and the results are enduring. Compared with baseline values, 61 of 69 patients (88 percent) have demonstrated significant improvements on all variables that have been sustained at the minimum of 60 months.
There is a high placebo response rate in migraineurs.22 Placebo responsiveness, however, is short-lived, and an 88 percent placebo effect lasting 5 years has never been documented. This article, coupled with our previous studies that have demonstrated between 83 and 92 percent positive outcomes, reduces the potential for the placebo effect playing a significant role in the outcome.
We have discussed the rationale for elimination or improvement of migraine headache following surgical treatment in our previous publications.9–12,20,21 Although the initial discovery of an improvement in migraine headache was merely serendipitous, our research team has made a concerted effort to find anatomical reasons for this improvement. We have designed surgical techniques and investigated why surgery may play a role in the amelioration of this disabling condition.13–16 There are still many unanswered questions, and our team continues its efforts to find more logical pathophysiological reasons for the surgical success that our patients have been enjoying.
Although the percentage of patients who observed complete elimination of migraine headache is not substantial in this study, our analysis of more recent results yields insight regarding improved surgical response, including elimination of migraine headache. The incidence of a positive response (at least 50 percent reduction) is currently over 90 percent, with over 70 percent showing complete elimination. We attribute this improvement in the outcomes to a series of factors. The most significant is the consequence of more accurate identification of migraine trigger sites. It was the failure to detect and deactivate the primary trigger sites that reduced the overall success rate. Better detection and deactivation of specific trigger sites has dramatically increased the success rate over the last 5 years. In addition, with experience more complete elimination of the triggering element has been possible. Specifically, the corrugator muscle group is being removed more thoroughly, and the nasal contact points and concomitant intranasal pathology, such as concha bullosa, are dealt with more aggressively. At the occipital trigger site, the crossover or entanglement between the occipital artery and the greater occipital nerves is eliminated by better exposure and removal of the occipital artery, if necessary. Furthermore, more attention is devoted by our team to identify patients with rebound headaches and narcotic dependency because, regardless of how successful the surgery may seem, the patients may still experience rebound headaches or could complain of pain due to addiction to opiates. Success of surgery is measured by its efficacy and taking into consideration the associated risks. Every adverse effect has been carefully documented throughout the study period. The recorded complications are listed in Table 3.
Beyond the four trigger sites discussed here, there are less common migraine headache entities involving the auriculotemporal branch of the trigeminal and lesser occipital nerves. The auriculotemporal trigger site is managed by removing the temporal artery23 as advocated by Sultaneh,24 and the lesser occipital site is dealt with by neurectomy and burying the tied end of the nerve in the muscle and injection of triamcinolone to reduce the potential for neuroma formation.
The results of this 5-year analysis were not compared with the control group who were only followed for 1 year. Based on the design of the initial study, most patients in the control group underwent surgical treatment at 1 year.
This study not only confirms our findings from previous studies that the surgical treatment of migraine headaches in properly selected patients is likely to succeed but it also provides evidence that the obtained results are enduring.
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