Treatment Response in Patients With Medication-Overuse Headache

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.

Study Overview

• Status: Recruiting
• Conditions: Headache; Treatment; Medication-overuse Headache; Greater Occipital Nerve Block
• Intervention / Treatment: Other: Treatment outcome

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Alper Mengi, MD; Phone Number: +90 537 651 03 85; Email: dralpmengi@gmail.com

Study Locations

• Turkey (Türkiye)
  • Edirne, Turkey (Türkiye), 22030
    • Recruiting
    • Sultan 1. Murat State Hospital
    • Contact: Alper Mengi; Phone Number: +90 5537 651 03 85; Email: dralpmengi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Treatment outcome; 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.
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	Other: Treatment outcome; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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."	Baseline

Collaborators and Investigators

• Sponsor: Sultan 1. Murat State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Headache; Headache Disorders, Secondary; Health Services Administration; Health Care Quality, Access, and Evaluation; Diagnosis; Health Care Evaluation Mechanisms; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Prognosis; Treatment Outcome
• Other Study ID Numbers: 29/12/2025-Number:13/8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: If requested, the data of the study will be shared by the researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No