Is Detoxification Needed in Medication-overuse Headache?

Not Applicable

• Conditions: Medication Overuse Headache
• Interventions: Other: Different well-known treatments

• Registration Number: NCT02993289
• Lead Sponsor: Danish Headache Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-24
• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-15
• Primary Completion: 2019-07-02
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-09
• Last Update Posted: 2020-06-11
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 115

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Detoxification	Different well-known treatments	Two months detoxification program with postponed pharmacological prophylactic treatment after ended detoxification.
Pharmacological prophylactic treatment	Different well-known treatments	Pharmacological prophylactic treatment from start without detoxification.
Detoxification and pharmacological prophylactic treatment	Different well-known treatments	Group A: Two months detoxification program combined with pharmacological prophylactic treatment from start.

Primary Outcome Measures

Name	Time	Method
Reduction in headache days per month in group A and C compared to group B.	Six months follow-up

Secondary Outcome Measures

Name	Time	Method
Reduction in headache days per month	Two and 12 months follow-up and 4 years	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).
Reduction in days/month with use of analgesics and/or migraine medication.	Two, 6 and 12 months follow-up and 4 years	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).
Responders based on reduction in headache days / month (percentage with more than 30%, 50% and 75%).	Two, 6 and 12 months follow-up and 4 years	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).
Reduction in headache intensity.	Two, 6 and 12 months follow-up and 4 years	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).
Descriptive report of self-reported adverse effects of treatments.	Two, 6 and 12 months follow-up	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).
Changes in Headache Under-Response to Treatment (HURT)-score.	Two, 6 and 12 months follow-up	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).
Drop-out rate.	One, 2, 4, 6, 9 and 12 months follow-up and 4 years
Changes in Hospital Anxiety and Depression Scale (HADS).	Six and 12 months follow-up	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).
Changes in Quality of Life (QoL) score.	Six and 12 months follow-up	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).
Changes in Severity of Dependence Score (SDS).	Six and 12 months follow-up	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).
Changes in Perceived Stress Score (PSS).	Twelve months follow-up.	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).
Patient's satisfaction questionnaire	Two, 6 and 12 months follow-up	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).

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Copenhagen, Denmark