Daily olive oil intake is feasible to reduce trigeminal neuralgia facial pain: A pilot study.

Extra virgin olive oil (EVOO) is thought to contribute to neuroprotection and, thus, may influence pain symptoms experienced by adults with demyelination-related trigeminal neuralgia (TN). This study aimed to determine the feasibility of daily intake of EVOO and its potential to alleviate facial pain of TN. Adults, self-reporting as female and affected by TN, were enrolled in a 16-week nonblinded, parallel study. After a 4-week baseline, participants were randomized to 60 mL/day EVOO or control (usual diet and no supplemental EVOO) for 12 weeks. Participants completed a daily questionnaire on pain intensity and compliance, the Penn Facial Pain Scale weekly, the 36-Item Short Form Survey monthly, and dietary assessment during baseline and intervention. Participants (n = 52; 53.3 ± 12.9 years) were recruited nationally; 42 completed the study. The EVOO group, with 90% intake compliance, showed significant decreases in the Penn Facial Pain Scale items of interference with general function, interference with orofacial function, and severity of pain from baseline, whereas the control group showed no improvements. EVOO benefit, compared with control, trended for the interference with orofacial function (P = .05). The 36-Item Short Form Survey items of role limitations resulting from emotional problems and role limitations from physical health favored EVOO. The EVOO group significantly improved their Healthy Eating Index 2015 component scores of fatty acids (primarily from increased oleic acid), sodium, and refined grains. EVOO intake of 60 mL/day was feasible for participants experiencing TN and may mitigate pain and improve quality of life. This trial was registered at clinicaltrials.gov (NCT05032573).

Design of Phase 3 Studies Evaluating Vixotrigine for Treatment of Trigeminal Neuralgia.

PURPOSE: Vixotrigine (BIIB074) is a voltage- and use-dependent sodium channel blocker. These studies will evaluate the efficacy and safety of vixotrigine in treating pain experienced by patients with trigeminal neuralgia (TN) using enriched enrollment randomized withdrawal trial designs. PATIENTS AND METHODS: Two double-blind randomized withdrawal studies are planned to evaluate the efficacy and safety of vixotrigine compared with placebo in participants with TN (NCT03070132 and NCT03637387). Participant criteria include ≥18 years old who have classical, purely paroxysmal TN diagnosed ≥3 months prior to study entry, who experience ≥3 paroxysms of pain/day. The two studies will include a screening period, 7-day run-in period, a 4- or 6-week single-dose-blind dose-optimization period (Study 1) or 4-week open-label period (Study 2), and 14-week double-blind period. Participants will receive vixotrigine 150 mg orally three times daily in the dose-optimization and open-label periods. The primary endpoint of both studies is the proportion of participants classified as responders at Week 12 of the double-blind period. Secondary endpoints include safety measures, quality of life, and evaluation of vixotrigine population pharmacokinetics. CONCLUSION: There is a need for an effective, well-tolerated, noninvasive treatment for the neuropathic pain associated with TN. The proposed studies will evaluate the efficacy and safety of vixotrigine in treating pain experienced by patients with TN.

Patterns of opioid use in patients with trigeminal neuralgia undergoing neurosurgery.

OBJECTIVE: First-line treatment for trigeminal neuralgia (TN) is pharmacological management using antiepileptic drugs (AEDs), e.g., carbamazepine (CBZ) and oxcarbazepine (OCBZ). Surgical intervention has been shown to be an effective and durable treatment for TN that is refractory to medical therapy. Despite the lack of evidence for efficacy in patients with TN, the authors hypothesized that patients with neuropathic facial pain are prescribed opioids at high rates, and that neurosurgical intervention may lead to a reduction in opioid use. METHODS: This is a retrospective study of patients with facial pain seen by a single neurosurgeon. All patients completed a survey on pain medications, medical comorbidities, prior interventions for facial pain, and a validated pain outcome tool (the Penn Facial Pain Scale). Patients subsequently undergoing neurosurgical intervention completed a survey at the 1-month follow-up in the office, in addition to telephone interviews using a standardized script between 1 and 6 years after intervention. Univariate and multivariate logistic regression were used to predict opioid use. RESULTS: The study cohort consisted of 309 patients (70% Burchiel type 1 TN [TN1], 18% Burchiel type 2 [TN2], 6% atypical facial pain [AFP], and 6% TN secondary to multiple sclerosis [TN-MS]). At initial presentation, 20% of patients were taking opioids. Of these patients, 55% were receiving concurrent opioid therapy with CBZ/OCBZ, and 84% were receiving concurrent therapy with at least one type of AED. Facial pain diagnosis (for diagnoses other than TN1, odds ratio [OR] 2.5, p = 0.01) and facial pain intensity at its worst (for each unit increase, OR 1.4, p = 0.005) were predictors of opioid use at baseline. Neurosurgical intervention led to a reduction in opioid use to 8% at long-term follow-up (p < 0.01, Fisher's exact test; n = 154). Diagnosis (for diagnoses other than TN1, OR 4.7, p = 0.002) and postintervention reduction in pain at its worst (for each unit reduction, OR 0.8, p < 10-3) were predictors of opioid use at long-term follow-up. On subgroup analysis, patients with TN1 demonstrated a decrease in opioid use to 5% at long-term follow-up (p < 0.05, Fisher's exact test), whereas patients with non-TN1 facial pain did not. In the nonsurgical group, there was no statistically significant decrease in opioid use at long-term follow-up (n = 81). CONCLUSIONS: In spite of its high potential for abuse, opioid use, mostly as an adjunct to AEDs, is prevalent in patients with facial pain. Opportunities to curb opioid use in TN1 include earlier neurosurgical intervention.

Measuring the impact of trigeminal neuralgia pain: the Penn Facial Pain Scale-Revised.

BACKGROUND AND OBJECTIVE: The Penn Facial Pain Scale (Penn-FPS) was originally developed as a supplemental module to the Brief Pain Inventory Pain Interference Index (BPI-PII) in order to fully assess the impact of trigeminal neuralgia (TN) pain on patients' health-related quality of life (HRQoL). The current objective is to create and establish the content validity of a new stand-alone version of the measure, the Penn-FPS-Revised (Penn-FPS-R). METHODS: Twenty participants (15 USA and 5 UK) with confirmed TN engaged in concept elicitation and cognitive debriefing interviews. These semi-structured interviews allowed participants to spontaneously describe the ways in which TN impacts on HRQoL and report on the extent to which the Penn-FPS and BPI-PII measure concepts are most relevant to them. Participants were also asked to report on the suitability of the instructions, recall period, and response options. RESULTS: Concept elicitation revealed nine themes involving TN restrictions on daily activities and HRQoL, including: "talking," "self-care," "eating," "eating hard foods/chewing foods," "daily activities," "activities with temperature change," "touching," "mood," and "relationships." Cognitive debriefing confirmed that all of the Penn-FPS concepts and some of the BPI-PII concepts ("mood," "general activities," and "relations with others") were relevant, although some items required edits to better capture individuals' experiences. The impact of temperature and/or weather on activities was also identified as an important concept that is not captured by the Penn-FPS or BPI-PII. Participants confirmed the acceptability of recall period, instructions, and response options. Results from the interviews were applied to create the Penn-FPS-R, a new brief outcome measure that assesses the impacts of TN most important to patients. CONCLUSION: The Penn-FPS-R is a new 12-item HRQoL outcome measure with content validity that can be used to assess and monitor the impact of TN treatment interventions in both clinical practice and research.

Endoscopic versus microscopic microvascular decompression for trigeminal neuralgia: equivalent pain outcomes with possibly decreased postoperative headache after endoscopic surgery.

OBJECTIVE Endoscopic surgery has revolutionized surgery of the ventral skull base but has not yet been widely adopted for use in the cerebellopontine angle. Given the relatively normal anatomy of the cerebellopontine angle in patients with trigeminal neuralgia (TN), the authors hypothesized that a fully endoscopic microvascular decompression (E-MVD) might provide pain outcomes equivalent to those of microscopic MVD (M-MVD) but with fewer complications. METHODS The authors conducted a single-institution, single-surgeon retrospective study with patients treated in the period of 2006-2013. Before surgery, all patients completed a questionnaire that included a validated multidimensional pain-outcome tool, the Penn Facial Pain Scale (PFPS, formerly known as Brief Pain Inventory-Facial), an 11-point scale that measures pain intensity, interference with general activities of daily living (ADLs), and facial-specific ADLs. Using a standardized script, independent research assistants conducted follow-up telephone interviews. RESULTS In total, 167 patients were available for follow-ups (66.5% female; 93 patients underwent M-MVD and 74 underwent E-MVD). Preoperative characteristics (i.e., TN classification, PFPS components, and medication use) were similar for the 2 surgical groups except for 2 variables. Patients in the M-MVD group had slightly higher incidence of V3 pain, and the 2 groups differed in the date of surgery and hence in the length of follow-up (2.4 years for the M-MVD group and 1.3 years for the E-MVD group, p < 0.05). There was a trend toward not finding neurovascular conflict at the time of surgery more frequently in the M-MVD than in the E-MVD group (11% vs 7%, p = 0.052). Internal neurolysis was more often performed in the E-MVD group (26% vs 7%, p = 0.001). The 2 groups did not significantly differ in the length of the MVD procedure (approximately 2 hours). Self-reported headaches at 1 month postoperatively were present in 21% of the patients in the M-MVD group versus 7% in the E-MVD group (p = 0.01). Pain outcomes at the most recent followup were equivalent, with patients reporting a 5- to 6-point (70%-80%) improvement in pain intensity, a 5-point (85%) improvement in pain interference with ADLs, and a 6-point (85%) improvement in interference with facial-specific ADLs. Actuarial freedom from pain recurrence was equivalent in the 2 groups, with 80% pain control at 3 years. CONCLUSIONS Both the fully endoscopic MVD and the conventional M-MVD appear to provide patients with equivalent pain outcomes. Complication rates were also similar between the groups, with the exception of the rate of headaches, which was significantly lower in the E-MVD group 1 month postoperatively.

Measurement of Trigeminal Neuralgia Pain: Penn Facial Pain Scale.

Pain is a subjective experience that cannot be directly measured. Therefore, patient-reported outcome is one of the currently accepted methods to capture pain intensity and its impact on activities of daily living. This article focuses on five patient-reported outcomes that have been used to measure trigeminal neuralgia pain-Visual Analog Scale, numeric rating scale, Barrow Neurological Institute Pain Intensity Score, McGill Pain Questionnaire, and Penn Facial Pain Scale. Each scale is evaluated for its practicality, applicability, comprehensiveness, reliability, validity, and sensitivity to measuring trigeminal neuralgia pain.