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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06203678
Other study ID # 23-3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2, 2024
Est. completion date March 1, 2025

Study information

Verified date January 2024
Source Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Contact Feyza Nur Yücel, Specialist
Phone 05385577059
Email dr.fny28@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Migraine is a common episodic headache disorder accompanied by neurological, gastrointestinal and autonomic changes.Migraine symptoms have a wide range, neck pain is seen in most migraine attacks, and accompanying neck pain is considered one of the important factors that increase migraine-related disability. It has been shown that various physical therapy methods applied to migraine patients with cervical myofascial pain reduce migraine pain and analgesic needs. One of the methods used in myofascial pain syndrome is kinesio taping and the effectiveness of cervical area applications has been shown in different studies.In this study, it was planned to examine the effect of kinesio taping applied to cervical trigger points on migraine symptoms in migraine patients.


Description:

The annual prevalence of migraine is approximately 15% and it is the second most common neurological disease worldwide. Migraine symptoms have a wide range, neck pain is seen in most migraine attacks, and accompanying neck pain is considered one of the important factors that increase migraine-related disability. In myofascial pain syndrome, active trigger points are considered as the source of pain and the treatment goal is to relax and inhibit these trigger points. It has been shown that various physical therapy methods applied to migraine patients with cervical myofascial pain reduce migraine pain and analgesic needs. In a study conducted with forty migraine patients, a significant decrease in headache parameters was reported with dry needling applied to the sternocleidomastoid muscle immediately after the procedure and at 1-month follow-up. Similarly, in migraine patients who received local anesthetic injection and topical analgesic treatment for cervical myofascial pain in addition to migraine prophylaxis, a decrease in attack frequency, severity and analgesic need was found compared to the control group.Kinesio taping is one of the most preferred conservative treatments for pain originating from the musculoskeletal system, and it is suggested that it provides an increase in blood and lymphatic flow by applying tension force on the skin with its elastic structure, and provides muscle relaxation with proprioceptive stimulation. In this study, it was planned to examine the effect of kinesiology taping applied to the cervical region on migraine symptoms in migraine patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date March 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Having a diagnosis of migraine without aura for at least 1 year according to the International Classification of Headache Disorders criteria - Being under migraine prophylactic treatment - Being between the ages of 18-65 - Physical examination reveals a cervical (trapezoidal and SCM) myofascial trigger point with a spreading pattern overlapping the migraine pain area. - Being literate - Agreeing to participate in the study Exclusion Criteria: - History of neck trauma, cervical radiculopathy and previous cervical surgery - Physical therapy, injection and manipulation to the cervical area in the last 3 months - History of fibromyalgia, active cancer, systemic inflammatory disease and infection - Pregnancy - Being <18 and >65 years old - Being illiterate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Kinesio taping
therapeutic tape application
Exercise
Cervical stretching and strengthening exercises home program
Sham taping
patch tape application

Locations

Country Name City State
Turkey Sultan Abdülhamid Han Training and Research Hospital Istanbul Uskudar

Sponsors (1)

Lead Sponsor Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Affaitati G, Costantini R, Tana C, Lapenna D, Schiavone C, Cipollone F, Giamberardino MA. Effects of topical vs injection treatment of cervical myofascial trigger points on headache symptoms in migraine patients: a retrospective analysis. J Headache Pain. — View Citation

Eigenbrodt AK, Ashina H, Khan S, Diener HC, Mitsikostas DD, Sinclair AJ, Pozo-Rosich P, Martelletti P, Ducros A, Lanteri-Minet M, Braschinsky M, Del Rio MS, Daniel O, Ozge A, Mammadbayli A, Arons M, Skorobogatykh K, Romanenko V, Terwindt GM, Paemeleire K, — View Citation

Gandolfi M, Geroin C, Vale N, Marchioretto F, Turrina A, Dimitrova E, Tamburin S, Serina A, Castellazzi P, Meschieri A, Ricard F, Saltuari L, Picelli A, Smania N. Does myofascial and trigger point treatment reduce pain and analgesic intake in patients und — View Citation

Rezaeian T, Ahmadi M, Mosallanezhad Z, Nourbakhsh MR. The impact of myofascial release and stretching techniques on the clinical outcomes of migraine headache: A randomized controlled trial. J Res Med Sci. 2021 Jul 31;26:45. doi: 10.4103/jrms.JRMS_745_18. — View Citation

Rezaeian T, Mosallanezhad Z, Nourbakhsh MR, Noroozi M, Sajedi F. Effects of Dry Needling Technique Into Trigger Points of the Sternocleidomastoid Muscle in Migraine Headache: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2020 Dec;99(12):1129-1137. — View Citation

Unlu Ozkan F, Soylu Boy FN, Erdem Kilic S, Geler Kulcu D, Bicer Ozdemir G, Cagliyan Hartevioglu H, Akpinar P, Aktas I. Clinical and radiological outcomes of kinesiotaping in patients with chronic neck pain: A double-blinded, randomized, placebo-controlled — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary headache index (HI) HI is calculate as mean migraine days per month (30 days) × mean migraine duration (h/day) × mean intensity (0-10 numeric rating scale). 3 months
Secondary Migraine day A migraine day is defined as the day on which migraine with or without aura or possible migraine occurs. 3 months
Secondary number of migraine days per month (30 days/month) number of migraine days per month (30 days/month) 3 months
Secondary migraine duration Migraine pain duration (hour) 3 months
Secondary numeric rating scale The numeric rating scale (NRS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain). 3 months
Secondary The Migraine Disability Assessment Test This scale is used to evaluate headache-related disability in migraine patients. Accordingly, 0-5 points; Stage 1, 6-10 points; Stage 2; 11-20 points; Stage 3; Scores of 21 points and above are classified as Stage 4, and as the stage increases, the severity of disability increases. 3 months
Secondary hospital anxiety and depression scale This scale is used to screen for anxiety and depression in individuals with physical illnesses.The scale consists of a total of 14 questions, 7 of which are anxiety and 7 depression, to be answered on a four-point Likert scale. A score above 10 for anxiety and 7 points for depression is considered significant. 3 months
Secondary 24-Hour Migraine Quality of Life Questionnaire (24-Hr MQoLQ) A 24-Hour Migraine Quality of Life Questionnaire (24-Hr MQoLQ) is a scale to measure the decrease of quality of life of a person within the past 24 hours after suffering of an acute migraine and taking migraine medication.The scale consists of 15 Likert-type questions scored in the range of 0-5, with higher scores indicating more deterioration in quality of life. 3 months
Secondary Cervical range of motion Cervical joint range of motion measurement with inclinometer (includes flexion, extension, lateral flexion and rotations) 3 months
Secondary Pressure pain threshold Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. Algometer is used in the measurement and low values are interpreted in favor of increased sensitivity. 3 months
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