Is Detoxification Needed in Medication-overuse Headache?

Danish Headache Center115 enrolled

Overview

Medication-overuse headache (MOH) is a disabling condition, yet treatable. According to European guidelines and based on evidence, multidisciplinary detoxification is the first choice of treatment for MOH. However, consensus about the details in such detoxification programs is lacking. Contrary, other headache specialists believe more in treating chronic headache with medication overuse with single-therapy of prophylaxis and no withdrawal of acute medication, based on randomized controlled double-blinded placebo trial with prophylaxes. Only a single RCT has compared single-therapy with prophylaxis to detoxification. However there was no significant difference. AIM: 1. To compare three different treatment protocols in order to improve the therapy of MOH. 2. To test several baseline variables for being potential predictors for good treatment outcome. 3. To examine the role of epigenetics in MOH.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

115

Conditions

Medication Overuse Headache

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Patients with medication-overuse headache: Inclusion Criteria: * Confirmed MOH diagnosis according to the ICHD-III beta (1). * Eligible for outpatient treatment based on type of medication overuse (without massive pure opioids and barbiturates overuse), and personal resources and motivation. * Capable of completing headache diary/calendar. * Age ≥ 18 years old and capable of providing informed consent. * Medication-overuse headache based on initial tension-type headache (TTH) or migraine. * Signed informed consent. Exclusion Criteria: * Severe physical illness or psychiatric disorders. * Addiction to alcohol or other drugs. * Current treatment with headache prophylaxis. Patients can be included minimum 5 weeks after stop of prophylaxis. * Pregnancy, breastfeeding or planned pregnancy within the next 12 months. * Inability to provide reliable information about medical history. Criteria for Control group 1 - Episodic migraineurs: * Episodic migraine, with/without concomitant tension-type headache, according to the ICHD-III beta. * Headache days / month ≤ 6 at time of inclusion. * Days with analgesics / month ≤ 6 at time of inclusion. * Prophylactics are allowed. * Age ≥ 18 years old. * Ability to fill out headache calendar. * No previous medication overuse. * No significant co-morbid pain, physical or psychiatric disorders. * No addiction to alcohol or drug-abuse. * No pregnancy, breastfeeding or planned pregnancy within the next 12 months. Criteria for Control group 2 - Healthy volunteers: •≥ 2 days with headache in the past month at time of inclusion. * Days with analgesics / month ≤ 6 at time of inclusion. * Age ≥ 18 years old. * No significant co-morbid pain, physical or psychiatric disorders. * No addiction to alcohol or drug-abuse. * No pregnancy, breastfeeding or planned pregnancy within the next 12 months.

Outcomes

Primary Outcomes

Reduction in headache days per month in group A and C compared to group B.

Time frame: Six months follow-up

Secondary Outcomes

Reduction in headache days per month

Time frame: Two and 12 months follow-up and 4 years

Reduction in days/month with use of analgesics and/or migraine medication.

Time frame: Two, 6 and 12 months follow-up and 4 years

Responders based on reduction in headache days / month (percentage with more than 30%, 50% and 75%).

Time frame: Two, 6 and 12 months follow-up and 4 years

Reduction in headache intensity.

1. Group A and C versus group B. 2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis). 3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis). This outcome will be presented as 1) Total headache intensity per month, and as 2) Visual Analogue Scale (VAS).

Time frame: Two, 6 and 12 months follow-up and 4 years

Descriptive report of self-reported adverse effects of treatments.

Time frame: Two, 6 and 12 months follow-up

Changes in Headache Under-Response to Treatment (HURT)-score.

Time frame: Two, 6 and 12 months follow-up

Drop-out rate.

Time frame: One, 2, 4, 6, 9 and 12 months follow-up and 4 years

Changes in Hospital Anxiety and Depression Scale (HADS).

Time frame: Six and 12 months follow-up

Changes in Quality of Life (QoL) score.

Time frame: Six and 12 months follow-up

Changes in Severity of Dependence Score (SDS).

Time frame: Six and 12 months follow-up

Changes in Perceived Stress Score (PSS).

Time frame: Twelve months follow-up.

Patient's satisfaction questionnaire

Time frame: Two, 6 and 12 months follow-up

Is Detoxification Needed in Medication-overuse Headache?

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes