Medication Overuse HeadacheNCT05608642
Intravenous Treatments Used in Medication Overuse Headache Bridge Treatment
A study testing Intravenous hydration, Intravenous prednisolone and Intravenous lidocaine in people with Medication Overuse Headache, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Medication Overuse Headache
- What is being tested?
- Intravenous hydration, Intravenous prednisolone and Intravenous lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medication overuse headache
- Chronic migraine
Who cannot join
- Other headaches will not accompany (tension-type headache, cluster...)
- Pregnancy
- Epilepsia
- Heart disease
- Bradikardia
- Hypertension
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazıt Teaching and Research Hospital
Ankara
About this study
Official title: Comparison of the Efficiency of Intravenous Treatments Used in Bridge Treatment of Medication Overuse Headache
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.
Read the 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.
- Conditions
- Medication Overuse Headache
- Being tested
- Intravenous hydration, Intravenous prednisolone, Intravenous lidocaine
- Keywords
- lidocaine, prednisolone, intravenous hydration
- Medical subject headings
- Headache Disorders, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous hydrationOther
500 cc intravenous serum for 1 hour in the first group service consists of patients who have been given.
Intravenous prednisoloneOther
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.
Intravenous lidocaineOther
The third group includes patients in whom 2 mg/kg of intravenous lidocaine is given by 1-hour infusion.
| Study group | Role | What they receive |
|---|---|---|
| Group given intravenous hydration | Active comparator | The first group consists of patients given 500 cc intravenous saline for 1 hour. Receives: Other: Intravenous hydration |
| Group given intravenous prednisolone | Active comparator | 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. Receives: Other: Intravenous prednisolone |
| Group given intravenous lidocaine | Active comparator | Third group; includes patients given 2 mg/kg intravenous lidocaine by 1-hour infusion. Receives: Other: Intravenous lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
It is a scale that measures the severity of pain. Scored between ''0: no pain'' and ''10: worst pain'' .
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start22 Oct 2022
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Overuse HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- Ömer Taylan Akkaya, Study chair, Diskapi Yildirim Beyazıt Teaching and Research HospitalGevher Rabia Genç Perdecioğlu, Study director, Diskapi Yildirim Beyazıt Teaching and Research HospitalHüseyin Alp Alptekin, Principal investigator, Diskapi Yildirim Beyazıt Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608642
- Sponsor's protocol ID
- Medication Overuse Headache
- Status last verified
- Nov 2022
- First submitted
- 23 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Intravenous Treatments Used in Bridge Treatment of Medication Overuse Headache
- ClinicalTrials.gov ID
- NCT05608642
- Acronym / sponsor ID
- Medication Overuse Headache
- Conditions
- Medication Overuse Headache
- Keywords
- lidocaine, prednisolone, intravenous hydration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 22 Oct 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group given intravenous hydration | Active comparator | Other: Intravenous hydrationThe first group consists of patients given 500 cc intravenous saline for 1 hour. |
| Group given intravenous prednisolone | Active comparator | Other: Intravenous prednisoloneSecond 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. |
| Group given intravenous lidocaine | Active comparator | Other: Intravenous lidocaineThird group; includes patients given 2 mg/kg intravenous lidocaine by 1-hour infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medication overuse headache
- Chronic migraine
Key exclusion criteria (7 listed)
- Other headaches will not accompany (tension-type headache, cluster...)
- Pregnancy
- Epilepsia
- Heart disease
- Bradikardia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous hydration500 cc intravenous serum for 1 hour in the first group service consists of patients who have been given. | Other | Group given intravenous hydration |
| Intravenous prednisoloneThe 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. | Other | Group given intravenous prednisolone |
| Intravenous lidocaineThe third group includes patients in whom 2 mg/kg of intravenous lidocaine is given by 1-hour infusion. | Other | Group given intravenous lidocaine |
Primary outcome
Visual analog scale (VAS)
Time frame: 4 weeks
It is a scale that measures the severity of pain. Scored between ''0: no pain'' and ''10: worst pain'' .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ömer Taylan Akkaya study chair
Diskapi Yildirim Beyazıt Teaching and Research Hospital
Gevher Rabia Genç Perdecioğlu study director
Diskapi Yildirim Beyazıt Teaching and Research Hospital
Hüseyin Alp Alptekin principal investigator
Diskapi Yildirim Beyazıt Teaching and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous hydration, Intravenous prednisolone and Intravenous lidocaine in people with Medication Overuse Headache, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.