The Effectiveness of Cervical Kinesio Taping in Migraine

January 2, 2024 updated by: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Feyza Nur Yücel, Specialist
  • Phone Number: +90 05385577059
  • Email: dr.fny28@gmail.com

Study Locations

  • Turkey
    • Uskudar
      • Istanbul, Uskudar, Turkey
        • Recruiting
        • Sultan Abdulhamid Han Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Kinesio taping+exercise

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 taping
therapeutic tape application
Other: Exercise
Cervical stretching and strengthening exercises home program
Placebo Comparator: Sham taping+exercise

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine day
Time Frame: 3 months
A migraine day is defined as the day on which migraine with or without aura or possible migraine occurs.
3 months
number of migraine days per month (30 days/month)
Time Frame: 3 months
number of migraine days per month (30 days/month)
3 months
migraine duration
Time Frame: 3 months
Migraine pain duration (hour)
3 months
numeric rating scale
Time Frame: 3 months
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
The Migraine Disability Assessment Test
Time Frame: 3 months
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
hospital anxiety and depression scale
Time Frame: 3 months
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
24-Hour Migraine Quality of Life Questionnaire (24-Hr MQoLQ)
Time Frame: 3 months
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
Cervical range of motion
Time Frame: 3 months
Cervical joint range of motion measurement with inclinometer (includes flexion, extension, lateral flexion and rotations)
3 months
Pressure pain threshold
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

  • Study Chair: Emre Ata, Assoc.Prof, Saglik Bilimleri Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no data sharing planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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