THE EFFECTS OF KINESIO®TAPING IN PATIENTS WITH MIGRAINE

THE EFFECTS OF KINESIO®TAPING ON PAIN, DISABILITY AND QUALITY OF LIFE IN PATIENTS WITH MIGRAINE: A RANDOMISED SINGLE-BLIND, PLACEBO-CONTROLLED TRIAL

In patients with migraine, neck pain and trigger points in the neck muscles are common in clinical practice. This study was to investigate whether kinesiotaping applied to the cervical muscles has a clinical effect on pressure pain threshold, disability and quality of life in patients with migraine.

Study Overview

• Status: Completed
• Conditions: Pain; Migraine
• Intervention / Treatment: Other: Kinesiotaping; Other: Placebo taping

Detailed Description

Patients with episodic migraine who were followed up by department of neurology in regional hospital will be included in the study. The Clinical Research Ethics committee approved the study (protocol no 10840098-604.01.1-E.6803).

Inclusion criterias are aged between 18-55 years, the patients with episodic migraine by neurologist according to ICHD-3 Beta criteria, patients with episodic migraine and associated neck pain, headache frequency in 1 month < 15 days and pain severity according to VAS above 40 mm.

Exclusion criterias are other headache types, contraindication for KT technique, cervical disc disorders, systemic rheumatic disease, fibromyalgia pain syndrome, myofascial pain syndrome, temporamandibular joint dysfunction, pregnancy, overuse medication, patients who had gotten rehabilitation programme before at least 3 months ago and anaesthetic blockage before at least 6 months ago.

All patients will allocate three groups. The patients with episodic migraine were randomly assigned to control group (n=20), placebo group (n=20) and experimental group (n= 20).

Outcome measures Demographic data and headache characteristics of the patients (frequency, duration, onset of headache, family history, onset age of headache, pain triggering factors, and localization of headache), presence of neck pain and disability of the last 1 month will evaluate before and after 6 weeks of treatment via self-administered questionnaire. Pressure Pain Algometry (Baseline Dolorimeter), Visual Analogue Scale (VAS), Neck Disability Index, Migraine Disability Assessment Scale (MIDAS) and Short Form-36 (SF-36) will use as the assessment method in the 6-week follow-up.

Intervention All two groups will give a 6-week exercise programme for 2 days per week. Exercise programme that included neck and head isotonic and isometric exercises show by physiotherapist. The participants will administer the exercises every day for 45 minutes. Sham taping will be applied for the placebo group. Kinesiotaping will be applied to the trapezius and deep cervical muscles twice a week for experimental group. The taping replace every 3 days.

Statistical Analyses Data will be expressed as mean, standard deviation and median. Significance between pre- and post-treatment pain, disability and quality of life variables was statistically significant with Paired Stutend's t - test and Wilcoxon signed rank tests; The differences between groups will be analysed using the Kruskal-Wallis-test to determine statistical significance. For statistical significance p <0.05 probability value will be accepted.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Düzce, Turkey
    • Duzce University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Inclusion criteria

• age between 18-55 years,
• the patients with episodic migraine by neurologist according to ICHD-3 Beta criteria,
• headache frequency in 1 month < 15 days and
• pain severity according to VAS above 40 mm.

Exclusion Criteria:

• other headache disorders
• disc disorders,
• systemic rheumatic disease, fibromyalgia pain syndrome, myofascial pain syndrome,
• temporamandibular joint dysfunction,
• pregnancy,
• overuse medication,
• patients who had gotten rehabilitation programme before at least 3 months ago and
• anaesthetic blockage before at least 6 months ago.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Experimental group will be applied Kinesotaping , exercise programme will be given.	Other: Kinesiotaping; Kinesiotaping (KT) is an approach that supports injured muscles and joints and helps relieve pain.; Other Names: exercise; sham taping
No Intervention: Control group; Exercise programme will be given.
Placebo Comparator: Placebo group; Sham taping will be applied, exercise programme will be given.	Other: Placebo taping; sham taping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale	Headache pain severity	Pretreatment- Posttreatment ( 6 weeks later)
visual analog scale	Neck pain severity	Pretreatment-Posttreatment (6 weeks later)
Baseline Dolorimeter	pressure pain threshold	pretreatment- Posttreatment ( 6 weeks later)
Clinical data questionnaire	clinical data	pretreatment- Posttreatment ( 6 weeks later)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short form-36	quality of life	pretreatment - Post treatment (6 weeks later)
MIDAS	Migraine Disability Assessment Scale (not score scale It describes the total of 3-month headache )	Pretreatment
Neck Disability Index	questionnaire to assess neck pain related disability	pretreatment - Post treatment (6 weeks later)

Collaborators and Investigators

• Sponsor: Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; Pain; Physiotherapy; Episodic Migraine; Disability; Kinesiotape; Pressure Pain Threshold
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 10840098-604.01.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No