Preventing Episodic Migraine With Caloric Vestibular Stimulation: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the safety and efficacy of a novel solid-state, caloric vestibular stimulation (CVS) device to provide adjuvant therapy for the prevention of episodic migraine in adult migraineurs. BACKGROUND: Migraine causes significant disability in ∼12% of the world population. No current migraine preventive treatment provides full clinical relief, and many exhibit high rates of discontinuation due to adverse events. Thus, new therapeutic options are needed. CVS may be an effective and safe adjuvant-therapy for the prevention of episodic migraine. METHODS: In a multicenter, parallel-arm, block-randomized, placebo-controlled clinical trial (clinicaltrials.gov: NCT01899040), subjects completed a 3-month treatment with the TNM™ device for CVS (refer to Fig. 2 for patient enrollment and allocation). The primary endpoint was the change in monthly migraine days from baseline to the third treatment month. Secondary endpoints were 50% responder rates, change in prescription analgesic usage and difference in total subjective headache-related pain scores. Device safety assessments included evaluation of any impact on mood, cognition, or balance. RESULTS: Per-protocol, active-arm subjects showed immediate and continued steady declines in migraine frequency over the treatment period. After 3 months of treatment, active-arm subjects exhibited significantly fewer migraine days (-3.9 ± 0.6 from a baseline burden of 7.7 ± 0.5 migraine days). These improvements were significantly greater than those observed in control subjects (-1.1 ± 0.6 from a baseline burden = 6.9 ± 0.7 migraine days) and represented a therapeutic gain of -2.8 migraine days, CI = -0.9 to -4.7, P = .012. Active arm subjects also reported greater reductions in acute medication usage and monthly pain scores compared to controls. No adverse effects on mood, cognition, or balance were reported. Subjects completed the trial with an average rate of 90% treatment adherence. No serious or unexpected adverse events were recorded. The rate of expected adverse events was similar across the active and the placebo groups, and evaluation confirmed that subject blinding remained intact. CONCLUSION: The TNM™ device for CVS appears to provide a clinically efficacious and highly tolerable adjuvant therapy for the prevention of episodic migraine.

Intrathecal normal saline without preservative does not have a local anesthetic effect.

The effects of intrathecally administered normal saline (preservative-free) were studied in patients undergoing differential spinal block anesthesia for evaluation of chronic pain below the waist. The injection of 5 ml saline did not significantly change the sensitivity to pinprick measured in the lower back and both lower extremities. Temperature measurement in both the lower extremities and psychogalvanic skin reflex did not show evidence of sympathetic block; the psychogalvanic skin reflex was abandoned because of inconsistent results. These findings refute the earlier conclusion of Urban and McKain who found that normal saline acts as a weak local anesthetic when injected intrathecally. We recommend use of normal saline (preservative-free) in 5 ml doses as a placebo for differential spinal block anesthesia.

Long-term use of narcotic/antidepressant medication in the management of phantom limb pain.

The successful management of 5 consecutive patients with intractable phantom limb pain is described. The main therapy is a combination of a narcotic and antidepressant. Medication remained effective during the average observation time of 22 months. There were no signs of habituation or addiction. We conclude that narcotics can be safely and successfully utilized for long-term management of phantom limb pain.