NCT07487649

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 17, 2026

Last Update Submit

March 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Headache severity

    Baseline

  • Post-injection pain severity

    Baseline

  • Headache-related disability

    Baseline

  • Pressure pain threshold

    Baseline

  • Anxiety and depression levels

    Baseline

  • +1 more secondary outcomes

Study Arms (2)

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

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

Interventions

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 groupTreatment success group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan 1. Murat State Hospital

Edirne, 22030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Headache Disorders, SecondaryHeadache

Interventions

Treatment Outcome

Condition Hierarchy (Ancestors)

Headache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PrognosisDiagnosisOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 23, 2026

Study Start

March 17, 2026

Primary Completion

May 30, 2026

Study Completion

May 30, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

If requested, the data of the study will be shared by the researchers.

Locations