Intensive Mindfulness Meditation Reduces Frequency and Burden of Migraine: An Unblinded Single-Arm Trial.

Objectives: Preventing migraine headaches and improving the quality of life for patients with migraine remains a challenge. We hypothesized intensive meditation training would reduce the disease burden of migraine. Method: An unblinded trial was analyzed as a single cohort exposed to a silent 10-day Vipassana meditation retreat that included 100 hr of sitting meditation. Participants with chronic or episodic migraine were enrolled and followed for 1 year. The primary outcome was a change in mean monthly migraine days at 12 months from baseline. Secondary outcomes included headache frequency and intensity, acute medication use, work days missed, home meditation, sleep quality, general health, quality of life, migraine impact, positive and negative affect, perceived stress, mindfulness, and pain catastrophizing. Results: Three hundred people were screened and 58 (19%) agreed to participate and enrolled in the intensive meditation training. Forty-six participants with chronic migraine (≥ 15 headaches/month of which ≥ 8 were migraines) and 12 with episodic migraine (< 15 and ≥ 4 migraines/month) attended and 45 (78%) completed the retreat. At 12 months, the average migraine frequency was reduced by 2.7 days (from 16.6 at baseline) per 28 days (95%CI - 4.3, - 1.3) and headaches by 3.4 (20.1 at baseline) per 28 days (- 4.9, - 1.9). Fifty percent responder rate was 29% for migraine. Acute medication use dropped by an average of 2.2 days (- 3.9, - 0.5) per 28 days, and participants reported 2.3 fewer days (- 4.0, - 0.5) on which they reduced their activity due to migraines. The most striking and promising effects were in several secondary outcomes, including migraine-specific quality of life, pain catastrophizing, and perceived stress. The significant improvements observed immediately following the intervention were sustained at 12 months follow-up. Conclusions: Training in Vipassana meditation via a 10-day retreat may reduce the frequency and burden of migraine. Preregistration: ClinicalTrials.gov: NCT00663585.

Use of a newly developed delivery device for percutaneous introduction of multiple lead configurations for spinal cord stimulation.

OBJECTIVE: The Epiducer lead delivery system is a novel lead delivery device that can be used to percutaneously implant S-Series paddle leads (St. Jude Medical, Plano, TX, USA) as well as multiple percutaneous leads obviating the need for laminectomy and/or multiple needle sticks, respectively. This study evaluates the safety and usage of the Epiducer lead delivery system. METHODS: An Institutional Review Board-approved observational data collection study was conducted to evaluate usage patterns of the Epiducer system. In addition to the number and frequency of different lead configurations, the following procedural aspects of the surgery were recorded during the evaluation: angle of entry, distance from entry to final lead placement, and physician feedback. Descriptive statistics on adverse events, procedural aspects, and patient outcomes were compiled. RESULTS: Data were collected from 163 patients across 25 investigational sites. Physicians successfully implanted patients using the Epiducer during 89% of the procedures. Seven possible lead configurations were implanted. There were 96% and 92% of physicians "satisfied" or "very satisfied" with accessing the epidural space and placing multiple leads with the Epiducer delivery system, respectfully. Eighty-nine percent of physicians were "satisfied" or "very satisfied" with implanting an S-Series paddle lead using the Epiducer delivery system. Ninety-five percent of physicians were "satisfied" or "very satisfied" with the Epiducer delivery system overall. Ten patients (6%) experienced adverse events. CONCLUSION: Results suggest that the Epiducer delivery system allows for the safe and successful percutaneous implantation of paddle leads and/or multiple lead configurations. Furthermore, physicians are satisfied with the Epiducer delivery system.

Occipital nerve pulsed radiofrequency treatment: a multi-center study evaluating predictors of outcome.

OBJECTIVE: Occipital neuralgia (ON) is a challenging condition for which there is no reference standard for treatment. The purpose of this study was to provide outcome data on the largest study to date evaluating pulsed radiofrequency (PRF) for ON and to determine whether any demographic, clinical, or treatment characteristics are associated with success. DESIGN: Retrospective data analysis was conducted in 102 subjects evaluating the effect of myriad factors on treatment success. SETTING: This study was conducted in academic civilian and military pain treatment centers. PATIENTS: One hundred and two consecutive patients with a primary diagnosis of ON were treated with PRF of the greater and/or lesser occipital nerve. OUTCOME MEASURES: A positive primary outcome was predefined as ≥50% pain relief lasting at least 3 months. The secondary outcome measure was procedural satisfaction. RESULTS: Fifty-two (51%) patients experienced ≥50% pain relief and satisfaction with treatment lasting at least 3 months. Variables associated with a positive outcome included a traumatic inciting event (65.7% success rate; P=0.03), lower diagnostic block volumes (odds ratio [OR]: 0.72; 95% confidence interval [CI]: 0.62-0.82; P<0.0001), and employment of multiple rounds of PRF (OR: 2.95; 95% CI: 1.77-4.92; P<0.0001). Factors correlating with treatment failure included extension of pain anterior to the scalp apex (OR: 0.32; 95% CI: 0.14-0.73; P=0.006) and ongoing secondary gain issues (OR: 0.19; 95% CI: 0.11-0.33; P<0.0001). CONCLUSION: PRF may provide intermediate-term benefit in ON to a significant proportion of refractory cases. Careful attention to selection criteria and treatment parameters may further improve treatment outcomes.