Chronic Migraine, HeadacheNCT06118190
Mesotherapy in the Treatment of Chronic Migraine
A study testing Lidocain in people with Chronic Migraine, Headache, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Mesotherapy is a type of injection frequently used in clinics. It is a treatment procedure that involves the injection of some drugs under the skin or into the skin. Mesotherapy is used in musculoskeletal system diseases, but it is reported that the effects of its use in migraine are uncertain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine, Headache
- What is being tested?
- Lidocain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 29 Oct 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
- Clinical diagnosis of chronic migraine disease
Who cannot join
- Infection disease
- Thyroid disease
- Anemia disease
- Systemic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanni Sultan Suleyman Research and Training Hospital
Istanbul, Kucukcekmece, 34303
About this study
Official title: The Effectiveness of Mesotherapy (Lidocaine and Proxicam) in the Treatment of Chronic Migraine
Mesotherapy is a type of injection frequently used in clinics. It is a treatment procedure that involves the injection of some drugs under the skin or into the skin. Mesotherapy is used in musculoskeletal system diseases, but it is reported that the effects of its use in migraine are uncertain.
Read the detailed description
Migraine is one of the types of headaches. For the diagnosis of chronic migraine, the headache must last more than 15 days. Nerve blocks, oral medication and neuromodulation are recommended for migraine treatment.Mesotherapy is a type of injection frequently used in clinics. It is a treatment procedure that involves the injection of some drugs under the skin or into the skin. Mesotherapy is used in musculoskeletal system diseases, but it is reported that the effects of its use in migraine are uncertain. This study was planned to show the effectiveness of mesotherapy in patients with migraine.
- Conditions
- Chronic Migraine, Headache
- Being tested
- Lidocain
- Keywords
- Mesotherapy, Chronic Migraine, pain, muscle, headache
- Medical subject headings
- Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocainDrug
Also called Proxicam
All participants treated with procaine and lidocaine injection for treatment.
| Study group | Role | What they receive |
|---|---|---|
| mesotherapy | Experimental | All participants who received mesotherapy were monitored regularly for the following three months to assess their prognosis and ensure patient adherence to treatment. Receives: Drug: Lidocain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
VAS rates pain on a scale of zero to 10. It is explained to the participant that 10 points means unbearable pain, zero points means no pain, and the patient is asked to rate his pain between zero and ten. Higher scores indicate increased pain severity
Measured: Baseline
Visual Analog Scale (VAS)
VAS rates pain on a scale of zero to 10. It is explained to the participant that 10 points means unbearable pain, zero points means no pain, and the patient is asked to rate his pain between zero and ten. Higher scores indicate increased pain severity
Measured: 4th week
Visual Analog Scale (VAS)
VAS rates pain on a scale of zero to 10. It is explained to the participant that 10 points means unbearable pain, zero points means no pain, and the patient is asked to rate his pain between zero and ten. Higher scores indicate increased pain severity
Measured: 8th week
Visual Analog Scale (VAS)
VAS rates pain on a scale of zero to 10. It is explained to the participant that 10 points means unbearable pain, zero points means no pain, and the patient is asked to rate his pain between zero and ten. Higher scores indicate increased pain severity
Measured: 12 th week
The frequency of painful days per month
The participant is asked how many days she/he feels pain in a month.Higher numbers indicate increased frequency of painful days
Measured: Baseline
The frequency of painful days per month
The participant is asked how many days she/he feels pain in a month.Higher numbers indicate increased frequency of painful days
Measured: 4th week
The frequency of painful days per month
The participant is asked how many days she/he feels pain in a month.Higher numbers indicate increased frequency of painful days
Measured: 8th week
The frequency of painful days per month
The participant is asked how many days she/he feels pain in a month.Higher numbers indicate increased frequency of painful days
Measured: 12th week
Secondary outcomes (8)
Duration of attack per month
The participant is questioned about how long each attack lasts within a month. Increased periods indicate prolonged symptom duration.
Measured: Baseline
Duration of attack per month
The participant is questioned about how long each attack lasts within a month. Increased periods indicate prolonged symptom duration.
Measured: 4th week
Duration of attack per month
The participant is questioned about how long each attack lasts within a month. Increased periods indicate prolonged symptom duration.
Measured: 8th week
Duration of attack per month
The participant is questioned about how long each attack lasts within a month. Increased periods indicate prolonged symptom duration.
Measured: 12th week
the number of analgesic per month
The participant is asked how many times he/she uses analgesic medication in a month. Higher numbers indicate an increased need for medical treatment
Measured: Baseline
the number of analgesic per month
The participant is asked how many times he/she uses analgesic medication in a month. Higher numbers indicate an increased need for medical treatment
Measured: 4th week
the number of analgesic per month
The participant is asked how many times he/she uses analgesic medication in a month. Higher numbers indicate an increased need for medical treatment
Measured: 8th week
the number of analgesic per month
The participant is asked how many times he/she uses analgesic medication in a month. Higher numbers indicate an increased need for medical treatment
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jan 2019
- Primary completion30 Dec 2020
- Study completion29 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Migraine, 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
- Not applicable
- Intervention model
- Single group
- Model description
- Retrospective analysis of the group that received treatment
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Ozyigit, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Elif Ozyigit, MD, Principal investigator, Kanuni Sultan Suleyman Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118190
- Sponsor's protocol ID
- KAEK/2022.11.225
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators were undecided
Publications
Costantino C, Marangio E, Coruzzi G. Mesotherapy versus Systemic Therapy in the Treatment of Acute Low Back Pain: A Randomized Trial. Evid Based Complement Alternat Med. 2011;2011:317183. doi: 10.1155/2011/317183. Epub 2010 Sep 1.
PubMed 20953425Ravishankar K, Tayade H, Mandlik R. Sublingual piroxicam in migraine without aura. J Assoc Physicians India. 2011 Aug;59:494-7.
PubMed 21887905
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Mesotherapy (Lidocaine and Proxicam) in the Treatment of Chronic Migraine
- ClinicalTrials.gov ID
- NCT06118190
- Acronym / sponsor ID
- KAEK/2022.11.225
- Conditions
- Chronic Migraine, Headache
- Keywords
- Mesotherapy, Chronic Migraine, pain, muscle, headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 29 Oct 2023 (actual)
- First posted
- 7 Nov 2023 (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.
Mesotherapy is a type of injection frequently used in clinics. It is a treatment procedure that involves the injection of some drugs under the skin or into the skin. Mesotherapy is used in musculoskeletal system diseases, but it is reported that the effects of its use in migraine are uncertain.
Detailed description
Migraine is one of the types of headaches. For the diagnosis of chronic migraine, the headache must last more than 15 days. Nerve blocks, oral medication and neuromodulation are recommended for migraine treatment.Mesotherapy is a type of injection frequently used in clinics. It is a treatment procedure that involves the injection of some drugs under the skin or into the skin. Mesotherapy is used in musculoskeletal system diseases, but it is reported that the effects of its use in migraine are uncertain. This study was planned to show the effectiveness of mesotherapy in patients with migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Retrospective analysis of the group that received treatment
| Arm | Type | Receives |
|---|---|---|
| mesotherapy | Experimental | Drug: LidocainAll participants who received mesotherapy were monitored regularly for the following three months to assess their prognosis and ensure patient adherence to treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of chronic migraine disease
Key exclusion criteria (4 listed)
- Infection disease
- Thyroid disease
- Anemia disease
- Systemic disease
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 |
|---|---|---|
| LidocainAlso: ProxicamAll participants treated with procaine and lidocaine injection for treatment. | Drug | mesotherapy |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Baseline
VAS rates pain on a scale of zero to 10. It is explained to the participant that 10 points means unbearable pain, zero points means no pain, and the patient is asked to rate his pain between zero and ten. Higher scores indicate increased pain severity
Visual Analog Scale (VAS)
Time frame: 4th week
VAS rates pain on a scale of zero to 10. It is explained to the participant that 10 points means unbearable pain, zero points means no pain, and the patient is asked to rate his pain between zero and ten. Higher scores indicate increased pain severity
Visual Analog Scale (VAS)
Time frame: 8th week
VAS rates pain on a scale of zero to 10. It is explained to the participant that 10 points means unbearable pain, zero points means no pain, and the patient is asked to rate his pain between zero and ten. Higher scores indicate increased pain severity
Visual Analog Scale (VAS)
Time frame: 12 th week
VAS rates pain on a scale of zero to 10. It is explained to the participant that 10 points means unbearable pain, zero points means no pain, and the patient is asked to rate his pain between zero and ten. Higher scores indicate increased pain severity
The frequency of painful days per month
Time frame: Baseline
The participant is asked how many days she/he feels pain in a month.Higher numbers indicate increased frequency of painful days
The frequency of painful days per month
Time frame: 4th week
The participant is asked how many days she/he feels pain in a month.Higher numbers indicate increased frequency of painful days
The frequency of painful days per month
Time frame: 8th week
The participant is asked how many days she/he feels pain in a month.Higher numbers indicate increased frequency of painful days
The frequency of painful days per month
Time frame: 12th week
The participant is asked how many days she/he feels pain in a month.Higher numbers indicate increased frequency of painful days
8 secondary outcomes
Duration of attack per month
Time frame: Baseline
Duration of attack per month
Time frame: 4th week
Duration of attack per month
Time frame: 8th week
Duration of attack per month
Time frame: 12th week
the number of analgesic per month
Time frame: Baseline
the number of analgesic per month
Time frame: 4th week
the number of analgesic per month
Time frame: 8th week
the number of analgesic per month
Time frame: 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 20953425Costantino C, Marangio E, Coruzzi G. Mesotherapy versus Systemic Therapy in the Treatment of Acute Low Back Pain: A Randomized Trial. Evid Based Complement Alternat Med. 2011;2011:317183. doi: 10.1155/2011/317183. Epub 2010 Sep 1.
- Background: PubMed 21887905Ravishankar K, Tayade H, Mandlik R. Sublingual piroxicam in migraine without aura. J Assoc Physicians India. 2011 Aug;59:494-7.
- Individual participant dataSharing planned: Undecided. The investigators were undecided
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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.
Elif Ozyigit, MD principal investigator
Kanuni Sultan Suleyman Research and Training 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 Lidocain in people with Chronic Migraine, Headache, run by Kanuni Sultan Suleyman Training 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 7 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06118190, which also lists 2 linked publications.
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 7 Nov 2023.