Migraine Clinical Trial
Official title:
Investigation of the Effectiveness of Cervical Kinesio Taping Taping Application on Headache Symptoms in Migraine.
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Sultan Abdülhamid Han Training and Research Hospital | Istanbul | Uskudar |
Lead Sponsor | Collaborator |
---|---|
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey |
Turkey,
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
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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