Clinical trial NCT06203678: The Effectiveness of Cervical Kinesio Taping in Migraine
Official title: Investigation of the Effectiveness of Cervical Kinesio Taping Taping Application on Headache Symptoms in Migraine.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Kinesio Taping
Keywords: Migraine
Kinesio taping
Headache
Neck pain
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: headache index (HI)
timeFrame: 3 months
Secondary outcomes:
measure: Migraine day
timeFrame: 3 months
measure: number of migraine days per month (30 days/month)
timeFrame: 3 months
measure: migraine duration
timeFrame: 3 months
measure: numeric rating scale
timeFrame: 3 months
measure: The Migraine Disability Assessment Test
timeFrame: 3 months
measure: hospital anxiety and depression scale
timeFrame: 3 months
measure: 24-Hour Migraine Quality of Life Questionnaire (24-Hr MQoLQ)
timeFrame: 3 months
measure: Cervical range of motion
timeFrame: 3 months
measure: Pressure pain threshold
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sultan Abdülhamid Han Training and Research Hospital
state: Uskudar
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Emre Ata, Assoc.Prof
role: STUDY_CHAIR
References:
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, Sacco S, Reuter U, Lampl C, Schytz HW, Katsarava Z, Steiner TJ, Ashina M. Diagnosis and management of migraine in ten steps. Nat Rev Neurol. 2021 Aug;17(8):501-514. doi: 10.1038/s41582-021-00509-5. Epub 2021 Jun 18.
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 undergoing onabotulinumtoxinA injection due to chronic intractable migraine? Eur J Phys Rehabil Med. 2018 Feb;54(1):1-12. doi: 10.23736/S1973-9087.17.04568-3. Epub 2017 Jul 27.
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. eCollection 2021.
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. doi: 10.1097/PHM.0000000000001504.
citation: 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. 2018 Nov 8;19(1):104. doi: 10.1186/s10194-018-0934-3.
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 study. Turk J Phys Med Rehabil. 2020 Nov 9;66(4):459-467. doi: 10.5606/tftrd.2020.5632. eCollection 2020 Dec.