Comparison of Two Different Migraine Acupuncture Treatment

NCT05351918 | Completed

• 1 other identifier: 0120-434/2021/7
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

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.

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.

Other: acupuncture

Interventions

acupuncture OTHER

Acupuncture points are punctured with needles.

consumption of analgesics; migrain days

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with migrain

You may qualify if:

• age \>18 years
• pragnancy

You may not qualify if:

• patients refusal

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jasmina Markovic - Bozic, PhD

  UMC LJUBLJANA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asist. prof., PhD

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 28, 2022
• Study Start: February 1, 2022
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

SL (1)