drugset / Trial / NCT04410536

Home Detox in Medication Overuse Headache (MOH) During Covid-19 Emergency

NCT04410536

NaSingle-groupOpen-labelTreatment

Summary

Medication Overuse Headache (MOH) is a disabling condition that affects the 2% of migraine population. Medication overuse (MO) makes this condition very difficult to treat. The literature of the last decades confirm the efficacy of withdrawal for patients with medication overuse, but it is also confirmed that patients have to be carefully followed after withdrawal to avoid relapses and to improve the clinical benefit of the therapeutic approach. Clinical results can be improved when traditional therapies are combined with behavioral approaches in particular mindfulness, that help patient to become more conscious about their symptoms and able to manage pain without medication. As the emergency situation due to the Corona-virus pandemic phenomenon in Italy, the regular clinical practice adopted for patients with CM-MO has changed in the last weeks: patients cannot come to the hospital for the withdrawal iv therapy and for regular follow up as the reduced mobility due to the emergency in particular in the Lombardia region, but all over Italy. So the investigators propose a pilot study to enforce the application of a Home-program for the withdrawal procedure for patients and the use of technology like smartphone and video calls so that patients can continue to be followed in their therapeutic process by using behavioral support and mindfulness practice. Patients will perform the withdrawal program at home, by oral administration of therapies, with specific instructions and education. Also the information for behavioral approach and mindfulness practice will be given, to use every day at home. Daily standardized mindfulness sessions of 12 minutes on their smartphone will be combined with weekly video-call to evaluate the clinical condition and to encourage the use strategies for pain management. Face-to-face visits at the follow up every three months will be scheduled. This modality will allow the patients to continue their therapeutic process and to be regularly followed during the one year after withdrawal.

Timeline

Start
2020-06-15
Primary completion
2021-12-31
Completion
2022-07-31

Drugs

EvaluationDrugModalityDoseRoute
Background Bromazepam Small molecule 1.5 mg Oral
Background Indomethacin Small molecule 50 mg Rectal
Background Indomethacin Small molecule 100 mg Rectal
Background Metoclopramide Small molecule Intramuscular
Background Pantoprazole Other / unclassified 40 mg Oral
Background Prednisone Other / unclassified 50 mg Oral

Indications