Medication-overuse HeadacheNCT07487649
Treatment Response in Patients With Medication-Overuse Headache
An observational study of Medication-overuse Headache and Treatment, run by Sultan 1. Murat State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study to evaluate pre-injection patient-related factors that may influence treatment response in patients with medication-overuse headache who underwent ultrasound-guided greater occipital nerve block. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Medication-overuse Headache, Treatment, Headache
- What is being tested?
- Treatment outcome
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Mar 2026to 30 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients who underwent ultrasound-guided greater occipital nerve block with a diagnosis of medication-overuse headache at Edirne Sultan 1. Murat State Hospital
Who may be able to join
- Age between 18 and 65 years
- Diagnosis of medication-overuse headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)
- Diagnosis of medication-overuse headache associated with the use of triptans or nonsteroidal anti-inflammatory drugs
- Previous diagnosis of chronic migraine or chronic tension-type headache according to the ICHD-3 criteria
Who cannot join
- History of severe head or neck trauma or previous neurosurgical intervention
- Presence of a severe psychiatric disorder (e.g., severe depression, schizophrenia)
- History of infectious disease, chronic inflammatory disease, or malignancy
- Previous diagnosis of secondary headache
- History of substance abuse
- Pregnancy or breastfeeding
Show all 9Show fewer
- History of an additional neurological disorder (e.g., cerebrovascular disease, multiple sclerosis)
- Difficulty with cooperation
- Presence of a concomitant systemic disease that may affect quality of life (e.g., congestive heart failure, chronic kidney disease, chronic liver disease, pulmonary disease, uncontrolled diabetes, or peripheral vascular disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Affecting Treatment Response in Patients With Medication-Overuse Headache Undergoing Greater Occipital Nerve Blockade
The aim of this study to evaluate pre-injection patient-related factors that may influence treatment response in patients with medication-overuse headache who underwent ultrasound-guided greater occipital nerve block.
- Being tested
- Treatment outcome
- Medical subject headings
- Headache Disorders, Secondary, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment outcomeOther
Before the injection, patients will be evaluated for the number of headache days, headache severity, the number of days of analgesic use for headache, headache-related disability, pressure pain threshold over the bilateral greater occipital nerve, anxiety and depression scores, and sleep quality. At 1 and 2 months after the injection, they will be reassessed for the number of headache days, headache severity, and the number of days of analgesic use for headache. In addition, at 1 hour after the injection, the pain experienced during the injection procedure will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Treatment success group | Patients who demonstrated a ≥50% reduction in the number of days of analgesic use for headache at the end of the second-month evaluation Receives: Other: Treatment outcome | |
| Treatment failure group | Patients who demonstrated a <50% reduction in the number of days of analgesic use for headache at the end of the second-month evaluation Receives: Other: Treatment outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of days of analgesic use for headache
Patients will be questioned the total number of days on which they used analgesics for headache during the past month.
Measured: Baseline
Secondary outcomes (6)
Headache severity
Patients will be questioned about headache severity using the Visual Analog Scale (VAS). A 10-cm-long horizontal straight line will be used for VAS assessment. 0 is considered no pain, and 10 is considered the most severe pain.
Measured: Baseline
Post-injection pain severity
Patients will be questioned about post-injection pain severity using the Visual Analog Scale (VAS). A 10-cm-long horizontal straight line will be used for VAS assessment. 0 is considered no pain, and 10 is considered the most severe pain.
Measured: Baseline
Headache-related disability
Patients will be questioned about headache-related disability using the Headache Impact Test-6 (HIT-6). The HIT-6 consists of six items, each scored on a 5-point Likert scale. The total score is calculated by summing the scores of all six items, with higher scores indicating a greater impact of headache on daily life.
Measured: Baseline
Pressure pain threshold
The pressure pain threshold over the bilateral greater occipital nerve will be assessed using a manual pressure algometer (Baseline Dolorimeter®). Pressure pain threshold measurement will be performed over the medial one-third of an imaginary line drawn between the external occipital protuberance and the mastoid process. During the measurement, the 1.52 cm² flat circular probe of the algometer will be placed on the relevant area, and pressure will be increased at a rate of 1 kg per second. Patients will be asked to indicate the moment they first perceived pain. The value for the reference area will be calculated as the arithmetic mean of the right and left measurements.
Measured: Baseline
Anxiety and depression levels
Patients' anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item scale consisting of two subscales: anxiety and depression. For each subscale, the minimum score is 0 and the maximum score is 21. Higher scores indicate greater severity of anxiety and depression symptoms.
Measured: Baseline
Sleep quality
Patients will be evaluated in terms of sleep quality using a 4-point Likert-type scale. They wii be asked to describe their sleep quality by selecting one of the following options: "good," "mildly impaired," "moderately impaired," or "severely impaired."
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start17 Mar 2026
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication-overuse HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan 1. Murat State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alper Mengi, Sultan 1. Murat State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487649
- Sponsor's protocol ID
- 29/12/2025-Number:13/8
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If requested, the data of the study will be shared by the researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Treatment Response in Patients With Medication-Overuse Headache Undergoing Greater Occipital Nerve Blockade
- ClinicalTrials.gov ID
- NCT07487649
- Acronym / sponsor ID
- 29/12/2025-Number:13/8
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sultan 1. Murat State HospitalOther government
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study to evaluate pre-injection patient-related factors that may influence treatment response in patients with medication-overuse headache who underwent ultrasound-guided greater occipital nerve block.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment success group | – | Other: Treatment outcomePatients who demonstrated a ≥50% reduction in the number of days of analgesic use for headache at the end of the second-month evaluation |
| Treatment failure group | – | Other: Treatment outcomePatients who demonstrated a <50% reduction in the number of days of analgesic use for headache at the end of the second-month evaluation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent ultrasound-guided greater occipital nerve block with a diagnosis of medication-overuse headache at Edirne Sultan 1. Murat State Hospital
Key inclusion criteria (4 listed)
- Age between 18 and 65 years
- Diagnosis of medication-overuse headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)
- Diagnosis of medication-overuse headache associated with the use of triptans or nonsteroidal anti-inflammatory drugs
- Previous diagnosis of chronic migraine or chronic tension-type headache according to the ICHD-3 criteria
Key exclusion criteria (9 listed)
- History of severe head or neck trauma or previous neurosurgical intervention
- Presence of a severe psychiatric disorder (e.g., severe depression, schizophrenia)
- History of infectious disease, chronic inflammatory disease, or malignancy
- Previous diagnosis of secondary headache
- History of substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment outcomeBefore the injection, patients will be evaluated for the number of headache days, headache severity, the number of days of analgesic use for headache, headache-related disability, pressure pain threshold over the bilateral greater occipital nerve, anxiety and depression scores, and sleep quality. At 1 and 2 months after the injection, they will be reassessed for the number of headache days, headache severity, and the number of days of analgesic use for headache. In addition, at 1 hour after the injection, the pain experienced during the injection procedure will be assessed. | Other | Treatment failure group, Treatment success group |
Primary outcome
the number of days of analgesic use for headache
Time frame: Baseline
Patients will be questioned the total number of days on which they used analgesics for headache during the past month.
6 secondary outcomes
Headache severity
Time frame: Baseline
Post-injection pain severity
Time frame: Baseline
Headache-related disability
Time frame: Baseline
Pressure pain threshold
Time frame: Baseline
Anxiety and depression levels
Time frame: Baseline
Sleep quality
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. If requested, the data of the study will be shared by the researchers.
Related trials for Medication-overuse Headache
Recruiting
Greater Occipital Nerve Block for Migraine With Medication Overuse Headache
Migraine Disorders, Medication Overuse Headache
Recruiting
Efficacy and Central Mechanisms of Electroacupuncture for Medication Overuse Headache
Medication Overuse Headache, Electroacupuncture
RecruitingObservational study
China HeadAche DIsorders RegiStry
Headache Disorders, Primary, Migraine
RecruitingObservational study
i-NEED: NEw migrainE Drugs Database
Episodic Migraine, Chronic Migraine
RecruitingObservational study
RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment
Migraine, Migraine With Aura
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication-overuse Headache and Treatment, run by Sultan 1. Murat State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of days of analgesic use for headache (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.