MigraineNCT06203678
The Effectiveness of Cervical Kinesio Taping in Migraine
A study testing Kinesio taping and Exercise in people with Migraine and Kinesio Taping, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Migraine, Kinesio Taping
- What is being tested?
- Kinesio taping and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 1 Mar 2025
- Phase
- Interventional
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan Abdülhamid Han Training and Research Hospital
Istanbul, Uskudar
Feyza Nur Yücel, specialist, 5385577059 ext. 90, dr.fny28@gmail.com
About this study
Official title: Investigation of the Effectiveness of Cervical Kinesio Taping Taping Application on Headache Symptoms in Migraine.
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.
Read the 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.
- Conditions
- Migraine, Kinesio Taping
- Being tested
- Kinesio taping, Exercise, Sham taping
- Keywords
- Migraine, Kinesio taping, Headache, Neck pain
- Medical subject headings
- Migraine Disorders, Headache, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapingOther
therapeutic tape application
ExerciseOther
Cervical stretching and strengthening exercises home program
Sham tapingOther
patch tape application
| Study group | Role | What they receive |
|---|---|---|
| Kinesio taping+exercise | Active comparator | Kinesio taping will be applied to the bilateral upper trapezius and sternocleidomastoid muscles by an experienced practitioner, once a week for 4 weeks.
Cervical stretching and strengthening exercises home program Receives: Other: Kinesio taping; Other: Exercise |
| Sham taping+exercise | Placebo comparator | Sham taping will be applied to the bilateral upper trapezius and sternocleidomastoid muscles once a week for 4 weeks, using patch tape of the same color as kinesio tape.
Cervical stretching and strengthening exercises home program Receives: Other: Exercise; Other: Sham taping |
| Exercise | Other | Cervical stretching and strengthening exercises home program Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (9)
Migraine day
A migraine day is defined as the day on which migraine with or without aura or possible migraine occurs.
Measured: 3 months
number of migraine days per month (30 days/month)
number of migraine days per month (30 days/month)
Measured: 3 months
migraine duration
Migraine pain duration (hour)
Measured: 3 months
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).
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Cervical range of motion
Cervical joint range of motion measurement with inclinometer (includes flexion, extension, lateral flexion and rotations)
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start2 Jan 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emre Ata, Assoc.Prof, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203678
- Sponsor's protocol ID
- 23-3
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no data sharing planned
Publications
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.
PubMed 34145431Gandolfi 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.
PubMed 28750504Rezaeian 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.
PubMed 34484377Rezaeian 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.
PubMed 32544109Affaitati 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.
PubMed 30409108Unlu 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.
PubMed 33364567
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Cervical Kinesio Taping Taping Application on Headache Symptoms in Migraine.
- ClinicalTrials.gov ID
- NCT06203678
- Acronym / sponsor ID
- 23-3
- Conditions
- Migraine, Kinesio Taping
- Keywords
- Migraine, Kinesio taping, Headache, Neck pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 12 Jan 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesio taping+exercise | Active comparator | Other: Kinesio taping, Other: ExerciseKinesio taping will be applied to the bilateral upper trapezius and sternocleidomastoid muscles by an experienced practitioner, once a week for 4 weeks. Cervical stretching and strengthening exercises home program |
| Sham taping+exercise | Placebo comparator | Other: Exercise, Other: Sham tapingSham taping will be applied to the bilateral upper trapezius and sternocleidomastoid muscles once a week for 4 weeks, using patch tape of the same color as kinesio tape. Cervical stretching and strengthening exercises home program |
| Exercise | Other | Other: ExerciseCervical stretching and strengthening exercises home program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Kinesio tapingtherapeutic tape application | Other | Kinesio taping+exercise |
| ExerciseCervical stretching and strengthening exercises home program | Other | Exercise, Kinesio taping+exercise, Sham taping+exercise |
| Sham tapingpatch tape application | Other | Sham taping+exercise |
Primary outcome
headache index (HI)
Time frame: 3 months
HI is calculate as mean migraine days per month (30 days) × mean migraine duration (h/day) × mean intensity (0-10 numeric rating scale).
9 secondary outcomes
Migraine day
Time frame: 3 months
number of migraine days per month (30 days/month)
Time frame: 3 months
migraine duration
Time frame: 3 months
numeric rating scale
Time frame: 3 months
The Migraine Disability Assessment Test
Time frame: 3 months
hospital anxiety and depression scale
Time frame: 3 months
24-Hour Migraine Quality of Life Questionnaire (24-Hr MQoLQ)
Time frame: 3 months
Cervical range of motion
Time frame: 3 months
Pressure pain threshold
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Results publication: PubMed 34145431Eigenbrodt 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.
- Results publication: PubMed 28750504Gandolfi 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.
- Results publication: PubMed 34484377Rezaeian 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.
- Results publication: PubMed 32544109Rezaeian 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.
- Results publication: PubMed 30409108Affaitati 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.
- Results publication: PubMed 33364567Unlu 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.
- Individual participant dataSharing planned: No. no data sharing planned
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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.
Emre Ata, Assoc.Prof study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio taping and Exercise in people with Migraine and Kinesio Taping, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Jan 2024. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feyza Nur Yücel, Specialist (05385577059 ext. +90, dr.fny28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
headache index (HI) (time frame: 3 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 NCT06203678, which also lists 6 linked publications.
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 12 Jan 2024.