Treatment Response in Patients With Medication-Overuse Headache
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSultan 1. Murat State Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients who underwent ultrasound-guided greater occipital nerve block with a diagnosis of medication-overuse headache at Edirne Sultan 1. Murat State Hospital
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Treatment outcome
Other interventionBefore 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 groups
70 Participants
are divided into 2 treatment groupsGroup A: Treatment success group1 intervention
Group B: Treatment failure group1 intervention
Trial outcomes
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.
Time frame
BaselineSecondary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Baseline3
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.
Time frame
Baseline4
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.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov