A randomized trial of bilateral greater occipital nerve blocks versus 10 peripheral nerve blocks for acute relief and prophylaxis of episodic migraine: A study protocol
This protocol paper details a single-center, randomized trial to compare greater occipital nerve blocks (GONBs) to multiple peripheral nerve blocks (MPNBs) for acute headache relief and prophylaxis in episodic migraine. GONBs are effective for the treatment and prevention of migraine, but a combination of trigeminal and occipital nerve blocks can be effective when GONBs alone have failed. To test this hypothesis, 60 adult participants will be randomized to receive either bilateral GONB or MPNBs of the bilateral greater occipital, lesser occipital, auriculotemporal, supraorbital, and supratrochlear nerves during an acute migraine with 0.5–1.25 mL bupivacaine 0.5%. Methylprednisolone 10–20 mg will be added only for the occipital nerves. Anesthesia in the distribution of each nerve block will be tested, and reinjection with bupivacaine will be performed until anesthesia is achieved. The primary endpoint will be pain freedom 20 min after injections. Secondary endpoints include pain freedom at 2 and 24 h, headache relief at 2 h, frequency and severity of subsequent migraine, and absenteeism from work/school/life events due to headaches over a 12-week follow-up period compared to a four-week run-in period. Trial Registration: The trial is registered at ClinicalTrials.gov (NCT04278573).
Intralesional Injection of Vitamin D3 for Treatment of Cutaneous Warts: A Randomized, Double-Blind, Placebo-Controlled Trial
Introduction: Treatment of cutaneous warts with intralesional vitamin D3 has demonstrated promising results in over 35 studies with methodological limitations. Methods: We conducted a randomized, double-blind, placebo-controlled trial in our primary care procedure clinic of intralesional vitamin D3 12 000 IU vs placebo in cutaneous warts every 4 weeks up to 3 times. Warts were assessed 4, 8, 12, and 24 weeks after the initial injection. The primary outcome was complete wart resolution. Reduction in wart size was a secondary outcome. Results: Between October 2020 and April 2023, we enrolled 77 participants with 1 or more cutaneous warts (41 and 36 in vitamin D3 and placebo groups, respectively) with untreated (32%) and recalcitrant (69%) warts. At 24 weeks, the index wart had resolved in 12 (30%) of vitamin D3 and 10 (31%) placebo participants. Treatment with vitamin D3 had no effect on wart surface area in an adjusted model nor wart resolution in analysis adjusted for baseline wart size, multiple warts, and the vehicle (OR 0.31 [95% CI] 0.01-10.3; P = 0.51). Conclusions: These results demonstrate a lack of benefit of intralesional vitamin D3 in cutaneous warts. ( ClinicalTrials.gov number NCT04278573)