Medication-overuse Headache Clinical Trial
Official title:
Efficacy of Restricted Acute Medication Intake Compared to no Acute Medication Intake During a Two Months Detoxification Period in Medication-overuse Headache
Medication-overuse headache (MOH) is a common, costly and disabling disorder affecting
approximately 63 million people worldwide. MOH is a potentially treatable condition, and
there are different opinions among headache specialists concerning the correct treatment
strategy.
The study is a prospective longitudinal open-label randomized controlled study comparing two
detoxification programs conducted in a tertiary headache care center. Patients with MOH are
either randomized to treatment in program A or program B. In program A, patients undergo
detoxification without any acute medication during a two months period (complete stop of
acute medication intake). In program B, patients was allowed to take up to 2 days a week with
analgesics or migraine medication during the two months detoxification period (restricted
acute medication intake). Both A and B are out-patient programs, and patients in both groups
receive patient education, consisting of six lessons, managed by specialized headache nurses
in collaboration with specialized psychologists and physiotherapists (Figure 1). All patients
are also offered rescue medication (levomepromazine or promethazine) and antiemetics, if
necessary.
The need for prophylactic treatment is evaluated individually after 2-month detoxification.
Patients are followed-up at 2, 6 and 12 months after detoxification. All patients are asked
to continuously register headache calendar and to fulfill questionnaires at all the follow-up
visits. In addition they are asked to fill out questionnaires (Headache Under-Response to
Treatment (HURT), Hospital Anxiety and Depression Score (HADS), Severity of Dependence Score
(SDS), World Health Organization Quality of Life Score(WHO QoL) and Dolo-score) at baseline,
2, 6 and 12 months
Patients with contact to Danish headache center are recruited consecutively. The
MOH-diagnosis is based on least 3 months previous detailed history and at least 1 month
fulfilled headache diary or headache calendar prior to the visit.
Patients were allocated to either program A or B by a concealed randomization process. The
patients were randomized in blocks of 10 by use of opaque, sealed envelopes.
Statistics Statistical Package for Social Sciences (SPSS) version 22 is used for statistical
calculations. Continuous variables are presented as mean (SD) and median (25-75 percentiles).
For normal distributed continuous variables the investigators use paired and unpaired
student's T-test, while for skewed distribution the investigators used Mann-Whitney test.
Categorical variables is presented as percentage (N), and analyzed by chi-square test. All
results are shown as intention-to-treat (ITT). The p-value is two-sided and p ≤ 0.05 is
considered as significant.
The primary outcome is reduction in headache days per month. Clinical relevant difference is
estimated to 20% between the two groups. The standard deviation based on previous published
literature was estimated to 35%. Accepting an alfa-error on 5% and 80% power, 80 patients are
needed. Based on previous studies, it is assumed that the drop-out rate will be approximately
15-20%. Therefore the investigators aim to include 100 patients corresponding to 50 in each
group.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02768233 -
Medication-overuse Headache: The Effect of a Patient Educational Programme as an add-on to Standard Treatment
|
N/A | |
| Recruiting |
NCT05528081 -
Longitudinal Study of the Patients With Medication-overuse Headache or Migraine That Completed Baseline MRI
|
||
| Completed |
NCT01314768 -
Brief Intervention for Medication Overuse Headache
|
N/A |