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Intravenous Treatments Used in Medication Overuse Headache Bridge Treatment

Primary Purpose

Medication Overuse Headache

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intravenous hydration
Intravenous prednisolone
Intravenous lidocaine
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medication Overuse Headache focused on measuring lidocaine, prednisolone, intravenous hydration

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Diskapi Yildirim Beyazıt Teaching and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group given intravenous hydration

Group given intravenous prednisolone

Group given intravenous lidocaine

Arm Description

The first group consists of patients given 500 cc intravenous saline for 1 hour.

Second group; consists of patients who were given 80 mg of intravenous prednisolone for the first 4 days and then given gradually decreasing doses of prednisolone in the following days.

Third group; includes patients given 2 mg/kg intravenous lidocaine by 1-hour infusion.

Outcomes

Primary Outcome Measures

Visual analog scale (VAS)
It is a scale that measures the severity of pain. Scored between ''0: no pain'' and ''10: worst pain'' .

Secondary Outcome Measures

Full Information

First Posted
October 23, 2022
Last Updated
November 2, 2022
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05608642
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 22, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Overuse Headache
Keywords
lidocaine, prednisolone, intravenous hydration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group given intravenous hydration
Arm Type
Active Comparator
Arm Description
The first group consists of patients given 500 cc intravenous saline for 1 hour.
Arm Title
Group given intravenous prednisolone
Arm Type
Active Comparator
Arm Description
Second group; consists of patients who were given 80 mg of intravenous prednisolone for the first 4 days and then given gradually decreasing doses of prednisolone in the following days.
Arm Title
Group given intravenous lidocaine
Arm Type
Active Comparator
Arm Description
Third group; includes patients given 2 mg/kg intravenous lidocaine by 1-hour infusion.
Intervention Type
Other
Intervention Name(s)
Intravenous hydration
Intervention Description
500 cc intravenous serum for 1 hour in the first group service consists of patients who have been given.
Intervention Type
Other
Intervention Name(s)
Intravenous prednisolone
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Intravenous lidocaine
Intervention Description
The third group includes patients in whom 2 mg/kg of intravenous lidocaine is given by 1-hour infusion.
Primary Outcome Measure Information:
Title
Visual analog scale (VAS)
Description
It is a scale that measures the severity of pain. Scored between ''0: no pain'' and ''10: worst pain'' .
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ömer Taylan Akkaya
Organizational Affiliation
Diskapi Yildirim Beyazıt Teaching and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gevher Rabia Genç Perdecioğlu
Organizational Affiliation
Diskapi Yildirim Beyazıt Teaching and Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hüseyin Alp Alptekin
Organizational Affiliation
Diskapi Yildirim Beyazıt Teaching and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diskapi Yildirim Beyazıt Teaching and Research Hospital
City
Ankara
Country
Turkey

12. IPD Sharing Statement

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Intravenous Treatments Used in Medication Overuse Headache Bridge Treatment

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