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NCT Number: NCT07487649

Treatment Response in Patients With Medication-Overuse Headache

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.

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Key information

Conditions

Medication-overuse Headache Brain Diseases Central Nervous System Diseases Greater Occipital Nerve Block Headache Headache Disorders Headache Disorders, Secondary Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Treatment

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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)

Treatment and study plan

Treatment outcome

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Headache severity

    Time frame: Baseline

    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.

  2. Post-injection pain severity

    Time frame: Baseline

    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.

  3. Headache-related disability

    Time frame: Baseline

    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.

  4. Pressure pain threshold

    Time frame: Baseline

    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.

  5. Anxiety and depression levels

    Time frame: Baseline

    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.

  6. Sleep quality

    Time frame: Baseline

    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."

Study contacts

Contact information is provided by the study sponsor or research team.

Alper Mengi, MD

CONTACT

[email protected]

+90 537 651 03 85

Sponsors and collaborators

Lead sponsor

Sultan 1. Murat State Hospital

Other Gov

Registry information

Official study title

Factors Affecting Treatment Response in Patients With Medication-Overuse Headache Undergoing Greater Occipital Nerve Blockade

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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