Treatment Response in Patients With Medication-Overuse Headache

Browse trials for

• Headache Disorders, Secondary 52
• Headache 1,226

Study population

Groups and cohorts

• 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

• OtherTreatment 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.

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: Baseline

Secondary 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: Baseline

2. 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: Baseline

3. 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: Baseline

4. 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: Baseline

5. 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.

   Time frame: Baseline

6. 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."

   Time frame: Baseline

Individual participant data

Plan to share: Yes — If requested, the data of the study will be shared by the researchers.