MigraineNCT05351918
Comparison of Two Different Migraine Acupuncture Treatment
An observational study of Migraine, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Headache is one of the most common clinical problems. Conventional drug therapy is more successful when complementary and integrative medicine approaches are combined to conventional treatment, as traditional Chinese medicine (TKM). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- acupuncture
- How many people
- 48 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Feb 2022to 15 Apr 2022
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with migrain
Who may be able to join
- age >18 years
- pragnancy
Who cannot join
- patients refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Migraine Treatment With Acupuncture: Comparison of Standard Protocol to Meridian Based Protocol
Headache is one of the most common clinical problems. Conventional drug therapy is more successful when complementary and integrative medicine approaches are combined to conventional treatment, as traditional Chinese medicine (TKM).
The success of acupuncture therapy depends on the selection of acupuncture points according to TKM pathological mechanisms. Correct selection of points are needed to treat migraine headaches.Acupuncture reduces the consumption of analgesics.
In this prospective, randomised study we will compered two methods of acupuncture stimulation: in the control group, all patients will receive the same local points, commonly used to treat migraine in our department, in the study group, local points will be selected according to the site of the headache.
Read the detailed description
Headache is one of the most common clinical problems. It is a subjective symptom that can be associated with many other syndromes. Conventional drug therapy is often effective in reducing of acute headache and also in the frequency and intensity of chronic headaches. However, the treatment is even more successful when complementary and integrative medicine approaches are combined to conventional treatment. The most commonly used method is traditional Chinese medicine (TKM).
Although acupuncture has been a key component of TKM for more than 2500 years, the mechanism of action is still not fully understood. Acupuncture needles probably stimulates the delta fibers, and thus the pain stimulus does not occur to the talamus. Acupuncture increases the activity of the opioidergic system by releasing serotonin, dopamine, neurotrophines and nitric oxide, which are effective in treating chronic pain and migraines. Acupuncture has been recognised by the WHO as a method for the treatment of acute and chronic pain. The success of acupuncture therapy depends on the selection of acupuncture points according to TKM pathological mechanisms. Correct selection of points are needed to treat migraine headaches. Local, regional and distal points are used. Acupuncture reduces the consumption of analgesics.
The research will be conducted in the clinical Department of Anaesthesiology and Intensive Care Therapy in University Medical Centre Ljubljana. Patients with migraine headaches will be included in the study. The quality of life after treatment, drug consumption, satisfaction and well-being will be monitored. The research will determine if targeted acupuncture stimulation regard to the location of headache reduces the frequency and severity of migraines compared to the established treatment method, thus reducing the number diabled days. The added value of the research is monitoring the quality of life after completed treatment, drug consumption and in satisfaction and well-being of the patient.
PROTOCOL
60 patients with migraine will be included in this prospective, randomised study, scheduled for acupuncture stimulation. Two methods of acupuncture stimulation will be compared. In all patients, DU 20 point and the same distal points will be used.
- ALL PATIENTS: DU 20 local points: Ex 1 distal points: LI 4, St 36, Liv 2
In the control group, all patients will receive the same local points, commonly used to treat migraine in our department.
- CONTROL GROUP: localn points: UB 2; GB 14, 16, 20 distal points: PC 6, SJ 5
In the study group, local points will be selected according to the site of the headache.
- Conditions
- Migraine
- Being tested
- acupuncture
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Acupuncture points are punctured with needles.
| Study group | Role | What they receive |
|---|---|---|
| migrain days | Two methods of acupuncture stimulation will be compared. In all patients, DU 20 point and the same distal points will be used.
In the control group, all patients will receive the same local points, commonly used to treat migraine in our department.
In the study group, local points will be selected according to the site of the headache. Receives: Other: acupuncture | |
| consumption of analgesics | Two methods of acupuncture stimulation will be compared. In all patients, DU 20 point and the same distal points will be used.
In the control group, all patients will receive the same local points, commonly used to treat migraine in our department.
In the study group, local points will be selected according to the site of the headache. Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
number disabled migraine days
The quality of life after treatment, drug consumption, satisfaction and well-being will be monitored. The research will determine if targeted acupuncture stimulation regard to the location of headache reduces the frequency and severity of migraines compared to the established treatment method, thus reducing the number diabled days. The added value of the research is monitoring the quality of life after completed treatment, drug consumption and in satisfaction and well-being of the patient.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Feb 2022
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasmina Markovic Bozic, University Medical Centre Ljubljana
- Investigators
- Jasmina Markovic - Bozic, PhD, Principal investigator, UMC LJUBLJANA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351918
- Sponsor's protocol ID
- 0120-434/2021/7
- Status last verified
- Nov 2022
- First submitted
- 15 Apr 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
1. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. 2. Goadsby PJ. Pathophysiology of migraine. Neurol Clin. 2009 May;27(2):335-60. 3. Zobdeh F, Kraiem AB, Attwood MM, et al. Pharmacological treatment of migraine: Drug classes, mechanisms of action, clinical trials and new treatments. Br J Pharmacol. 2021 Dec;178(23):4588-4607. 4. Millstine D, Chen CY, Bauer B. Complementary and integrative medicine in the management of headache. BMJ. 2017 May 16;357:j1805. 5. Rajapakse T, Pringsheim T. Nutraceuticals in Migraine: A Summary of Existing Guidelines for Use. Headache. 2016 Apr;56(4):808-16. 6. Rožman P, Osojnik J. Tradicionalna kitajska medicina in akupunktura, 1.del. Slovensko društvo za orientalno medicino. Ljubljana. 1993. 7. Lozano F. Pattern Discrimination in Traditional Chinese Medicine (TCM). In: Lin YC, Hsu EZ, eds. Acupuncture for Pain Management. New York: Springer; 2014. p. 45-72 8. Zhao L, Chen J, Li Y, et al. The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial. JAMA Intern Med. 2017 Apr 1;177(4):508-515. 9. Liu Y, Yu S. Recent Approaches and Development of Acupuncture on Chronic Daily Headache. Curr Pain Headache Rep. 2016 Jan;20(1):4. 10. Langevin HM, Bouffard NA, Badger GJ, et al. Subcutaneous tissue fibroblast cytoskeletal remodeling induced by acupuncture: evidence for a mechanotransduction-based mechanism. J Cell Physiol. 2006 Jun;207(3):767-74. 11. Keown D. The spark in the machine. London and Philadelphia: Singing Dragon; 2014. 12. Hwang YC, Lee IS, Ryu Y, et al. Exploring traditional acupuncture point selection patterns for pain control: data mining of randomised controlled clinical trials. Acupunct Med. 2020 Jun 20 13. Silva Andrade B, Siqueira S, de Assis Soares WR, et al. Long-COVID and Post-COVID Health Complications: An Up-to-Date Review on Clinical Conditions and Their Possible Molecular Mechanisms. Viruses. 2021 Apr 18;13(4):700. 14. Martelletti P, Bentivegna E, Spuntarelli V, et al. Long-COVID Headache. SN Compr Clin Med. 2021;3(8):1704-1706.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine Treatment With Acupuncture: Comparison of Standard Protocol to Meridian Based Protocol
- ClinicalTrials.gov ID
- NCT05351918
- Acronym / sponsor ID
- 0120-434/2021/7
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 28 Apr 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.
Headache is one of the most common clinical problems. Conventional drug therapy is more successful when complementary and integrative medicine approaches are combined to conventional treatment, as traditional Chinese medicine (TKM).
The success of acupuncture therapy depends on the selection of acupuncture points according to TKM pathological mechanisms. Correct selection of points are needed to treat migraine headaches.Acupuncture reduces the consumption of analgesics.
In this prospective, randomised study we will compered two methods of acupuncture stimulation: in the control group, all patients will receive the same local points, commonly used to treat migraine in our department, in the study group, local points will be selected according to the site of the headache.
Detailed description
Headache is one of the most common clinical problems. It is a subjective symptom that can be associated with many other syndromes. Conventional drug therapy is often effective in reducing of acute headache and also in the frequency and intensity of chronic headaches. However, the treatment is even more successful when complementary and integrative medicine approaches are combined to conventional treatment. The most commonly used method is traditional Chinese medicine (TKM).
Although acupuncture has been a key component of TKM for more than 2500 years, the mechanism of action is still not fully understood. Acupuncture needles probably stimulates the delta fibers, and thus the pain stimulus does not occur to the talamus. Acupuncture increases the activity of the opioidergic system by releasing serotonin, dopamine, neurotrophines and nitric oxide, which are effective in treating chronic pain and migraines. Acupuncture has been recognised by the WHO as a method for the treatment of acute and chronic pain. The success of acupuncture therapy depends on the selection of acupuncture points according to TKM pathological mechanisms. Correct selection of points are needed to treat migraine headaches. Local, regional and distal points are used. Acupuncture reduces the consumption of analgesics.
The research will be conducted in the clinical Department of Anaesthesiology and Intensive Care Therapy in University Medical Centre Ljubljana. Patients with migraine headaches will be included in the study. The quality of life after treatment, drug consumption, satisfaction and well-being will be monitored. The research will determine if targeted acupuncture stimulation regard to the location of headache reduces the frequency and severity of migraines compared to the established treatment method, thus reducing the number diabled days. The added value of the research is monitoring the quality of life after completed treatment, drug consumption and in satisfaction and well-being of the patient.
PROTOCOL
60 patients with migraine will be included in this prospective, randomised study, scheduled for acupuncture stimulation. Two methods of acupuncture stimulation will be compared. In all patients, DU 20 point and the same distal points will be used.
- ALL PATIENTS: DU 20 local points: Ex 1 distal points: LI 4, St 36, Liv 2
In the control group, all patients will receive the same local points, commonly used to treat migraine in our department.
- CONTROL GROUP: localn points: UB 2; GB 14, 16, 20 distal points: PC 6, SJ 5
In the study group, local points will be selected according to the site of the headache.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| migrain days | – | Other: acupunctureTwo methods of acupuncture stimulation will be compared. In all patients, DU 20 point and the same distal points will be used. In the control group, all patients will receive the same local points, commonly used to treat migraine in our department. In the study group, local points will be selected according to the site of the headache. |
| consumption of analgesics | – | Other: acupunctureTwo methods of acupuncture stimulation will be compared. In all patients, DU 20 point and the same distal points will be used. In the control group, all patients will receive the same local points, commonly used to treat migraine in our department. In the study group, local points will be selected according to the site of the headache. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with migrain
Key inclusion criteria (2 listed)
- age >18 years
- pragnancy
Key exclusion criteria (1 listed)
- patients refusal
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 |
|---|---|---|
| acupunctureAcupuncture points are punctured with needles. | Other | consumption of analgesics, migrain days |
Primary outcome
number disabled migraine days
Time frame: 6 months
The quality of life after treatment, drug consumption, satisfaction and well-being will be monitored. The research will determine if targeted acupuncture stimulation regard to the location of headache reduces the frequency and severity of migraines compared to the established treatment method, thus reducing the number diabled days. The added value of the research is monitoring the quality of life after completed treatment, drug consumption and in satisfaction and well-being of the patient.
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 9 Nov 2022.
- Background1. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. 2. Goadsby PJ. Pathophysiology of migraine. Neurol Clin. 2009 May;27(2):335-60. 3. Zobdeh F, Kraiem AB, Attwood MM, et al. Pharmacological treatment of migraine: Drug classes, mechanisms of action, clinical trials and new treatments. Br J Pharmacol. 2021 Dec;178(23):4588-4607. 4. Millstine D, Chen CY, Bauer B. Complementary and integrative medicine in the management of headache. BMJ. 2017 May 16;357:j1805. 5. Rajapakse T, Pringsheim T. Nutraceuticals in Migraine: A Summary of Existing Guidelines for Use. Headache. 2016 Apr;56(4):808-16. 6. Rožman P, Osojnik J. Tradicionalna kitajska medicina in akupunktura, 1.del. Slovensko društvo za orientalno medicino. Ljubljana. 1993. 7. Lozano F. Pattern Discrimination in Traditional Chinese Medicine (TCM). In: Lin YC, Hsu EZ, eds. Acupuncture for Pain Management. New York: Springer; 2014. p. 45-72 8. Zhao L, Chen J, Li Y, et al. The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial. JAMA Intern Med. 2017 Apr 1;177(4):508-515. 9. Liu Y, Yu S. Recent Approaches and Development of Acupuncture on Chronic Daily Headache. Curr Pain Headache Rep. 2016 Jan;20(1):4. 10. Langevin HM, Bouffard NA, Badger GJ, et al. Subcutaneous tissue fibroblast cytoskeletal remodeling induced by acupuncture: evidence for a mechanotransduction-based mechanism. J Cell Physiol. 2006 Jun;207(3):767-74. 11. Keown D. The spark in the machine. London and Philadelphia: Singing Dragon; 2014. 12. Hwang YC, Lee IS, Ryu Y, et al. Exploring traditional acupuncture point selection patterns for pain control: data mining of randomised controlled clinical trials. Acupunct Med. 2020 Jun 20 13. Silva Andrade B, Siqueira S, de Assis Soares WR, et al. Long-COVID and Post-COVID Health Complications: An Up-to-Date Review on Clinical Conditions and Their Possible Molecular Mechanisms. Viruses. 2021 Apr 18;13(4):700. 14. Martelletti P, Bentivegna E, Spuntarelli V, et al. Long-COVID Headache. SN Compr Clin Med. 2021;3(8):1704-1706.
- Individual participant dataSharing planned: 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.
Jasmina Markovic - Bozic, PhD principal investigator
UMC LJUBLJANA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 1 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 9 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 Slovenia. 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?
number disabled migraine days (time frame: 6 months). 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 NCT05351918, which also lists 1 linked publication.
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 9 Nov 2022.