Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04410536 |
| Other study ID # |
MOH |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2020 |
| Est. completion date |
July 2022 |
Study information
| Verified date |
October 2020 |
| Source |
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta |
| Contact |
Licia Grazzi, MD |
| Phone |
+39022394 |
| Email |
licia.grazzi[@]istituto-besta.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Background and significance Medication Overuse Headache (MOH) is a disabling pain syndrome
with a prevalence of 2% in the general population, and which affects patients suffering from
primary headaches, mainly those with Chronic Migraine (CM). This condition is very difficult
to treat. The literature of the last decades confirmed the need to stop overuse through
withdrawal (or detoxification programs) as an essential step in the treatment strategy , and
high rates of successful outcomes are reported by several studies and reviews, although not
all patients receiving treatment are able to stop MO or to reduce significantly the frequency
of headaches. Remission rates range from 60% to 83% in studies with a 1-year follow-up, with
an average relapse rate into MOH of 32.8% in a review on several studies from different
countries, which is similar to the relapse into CM of 21.5% and into MOH of 33.9% found in a
sample from our group . Literature data showed that patients need to be carefully followed
after withdrawal to avoid relapses in overuse and to improve the clinical benefit, adding
anti-migraine prophylaxi . Furthermore, different clinical experiences confirmed the
effectiveness of interventions based on out-patient withdrawal programs and education and
support to the correct use of medications to patients, and published evidence - also from our
research group - supports the role of standardized behavioural approaches . The aspect of
feasibility of these treatments is not regularly reported in published studies, but it can be
estimated that a proportion of patients discontinue the treatment protocols, with a drop-out
rate around 15-20% at one year from withdrawal., as it was 11% after 6 months, and 18% after
1 year in the seminal study by Katsarawa et al, and 9% after one year from withdrawal in a
previous study from our research group . According to our protocols at the Headache Center,
the withdrawal program is performed at hospital, either in an in-patient setting or in
day-hospital setting. This program includes abrupt interruption of the overused drugs,
intravenous therapy, educational support, rescue treatments for severe headaches, and
prescription of a specific pharmacological prophylaxis for migraine prevention. Furthermore,
standardized behavioural therapies are used during the treatment period, and during the
follow up, particularly by approaches based on mindfulness practice - which usually delivered
in groups of 4 - 8 patients . This approach may be particularly useful in helping patients to
obtain a better outcome. All the above discussed considerations are even more relevant in
this emergency situation due to the Corona-virus pandemic phenomenon in Italy, with its
consequences on mobility of patients and clinical practice. In order to promote different
modalities to respond to the needs of patients suffering from this disabling condition during
the emergency, exercise-based telemedicine and smartphone applications seem very appropriate,
as they have been recently tested in the management of chronic pain conditions . This
preliminary study will be performed considering that the Covid-19 emergency reduced
significantly our possibility to hospitalize patients for withdrawal treatments as well as
the mobility of patients, particularly those living in other Italian regions than Lombardy,
and in view of providing an effective and somewhat innovative treatment program for MOH and
CM patients. The proposed treatment intervention is based on our experience, and on published
reports, but it specifically includes a home based withdrawal program, several visits
performed as Video calls, and educational and support strategies aimed to develop skills to
reduce overuse and to cope with pain by a standardized behavioural approach based on
mindfulness - which will be delivered mainly by telemedicine and smartphone applications. The
aim of this pilot study is to assess the feasibility and the effectiveness at long-term on
relevant outcomes of a specific protocol, designed to be appropriate during the emergency
situation due to COVID-19 epidemic, by an approach that is alternative to current practice,
particularly as far as avoiding the need for hospitalization, reducing face-to-face hospital
visits taking advantage of facilities offered by new technologies, besides including
innovative and emerging treatment choices, namely a behavioural approach base on mindfulness.
