NCT06203678

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

January 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

January 2, 2024

Last Update Submit

January 2, 2024

Conditions

Keywords

MigraineKinesio tapingHeadacheNeck pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Migraine day

    3 months

  • number of migraine days per month (30 days/month)

    3 months

  • migraine duration

    3 months

  • numeric rating scale

    3 months

  • The Migraine Disability Assessment Test

    3 months

  • +4 more secondary outcomes

Study Arms (3)

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

Other: Kinesio tapingOther: 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

Other: ExerciseOther: Sham taping

Exercise

OTHER

Cervical stretching and strengthening exercises home program

Other: Exercise

Interventions

therapeutic tape application

Kinesio taping+exercise

Cervical stretching and strengthening exercises home program

ExerciseKinesio taping+exerciseSham taping+exercise

patch tape application

Sham taping+exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale patients diagnosed with migraine
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan Abdülhamid Han Training and Research Hospital

Istanbul, Uskudar, Turkey (Türkiye)

RECRUITING

Related Publications (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Migraine DisordersHeadacheNeck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Emre Ata, Assoc.Prof

    Saglik Bilimleri Universitesi

    STUDY CHAIR

Central Study Contacts

Feyza Nur Yücel, Specialist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 12, 2024

Study Start

January 2, 2024

Primary Completion

December 1, 2024

Study Completion

March 1, 2025

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

no data sharing planned

Locations