Clinical trial NCT05608642: Intravenous Treatments Used in Medication Overuse Headache Bridge Treatment
Official title: Comparison of the Efficiency of Intravenous Treatments Used in Bridge Treatment of Medication Overuse Headache
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medication Overuse Headache
Keywords: lidocaine
prednisolone
intravenous hydration
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Medication overuse headache is the chronicity of headaches, which occurs more than 15 days a month, as a result of frequent use of painkillers, opioids or migraine attack drugs (ergotamine, triptan) in individuals with pre-existing primary headache disease.

In the treatment of this headache, two ways can be followed as slow drug discontinuation or sudden drug discontinuation. The most commonly used method is the sudden discontinuation of the overused analgesic agent, the initiation of prophylactic treatment, and then the application of bridge therapy for 6-10 days. Intravenous hydration, steroids, antiemetics, neuroleptic drugs and local anesthetic drugs such as lidocaine can be used in bridge treatment.

Detailed description: In our clinic, we routinely apply intravenous 1.5 mg/kg lidocaine, intravenous prednisolone and intravenous saline treatments as bridge treatment to patients diagnosed with medication overuse headache. In this study, we aimed to compare the efficacy of intravenous lidocaine, intravenous steroids and intravenous hydration therapy, which were used as bridge therapy after the cessation of analgesic use in patients with medication overuse headache.

Patients who applied to the algology outpatient clinic and who were diagnosed with drug overuse headache and treated were evaluated by dividing them into 3 different groups. It was planned to include 15 patients in each group. The first group consists of patients who were given 500 cc of intravenous saline for 1 hour in the service. The second group consisted of patients who were given 80 mg intravenous prednisolone for the first 4 days and then gradually reduced doses of prednisolone in the following days. The third group includes patients in whom 2 mg/kg intravenous lidocaine was administered as a 1-hour infusion, monitored in the ward.

Pain intensity will be evaluated by visual analog scale (VAS) in all patients after treatment, at 1 month and 3 months. In addition, the number of days with pain and the number of analgesics used in the 3-month period after the end of the treatment will be evaluated and the Quality of Life Scale will be applied.

Eligibility criteria: Inclusion Criteria:

* Medication overuse headache
* Chronic migraine

Exclusion Criteria:

* Other headaches will not accompany (tension-type headache, cluster...)
* Pregnancy
* Epilepsia
* Heart disease
* Bradikardia
* Hypertension
* Diabetes mellitus

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazıt Teaching and Research Hospital
Study officials:
affiliation: Diskapi Yildirim Beyazıt Teaching and Research Hospital
name: Ömer Taylan Akkaya
role: STUDY_CHAIR
affiliation: Diskapi Yildirim Beyazıt Teaching and Research Hospital
name: Gevher Rabia Genç Perdecioğlu
role: STUDY_DIRECTOR
affiliation: Diskapi Yildirim Beyazıt Teaching and Research Hospital
name: Hüseyin Alp Alptekin
role: PRINCIPAL_INVESTIGATOR
References: