THE EFFECTS OF KINESIO®TAPING IN PATIENTS WITH MIGRAINE

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04185714
• Other study ID #: 10840098-604.01.1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: May 2021
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Pain

Intervention

Other:
• Kinesiotaping
Kinesiotaping (KT) is an approach that supports injured muscles and joints and helps relieve pain.
• Placebo taping
sham taping

Locations

Country	Name	City	State
Turkey	Duzce University	Düzce

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale	Headache pain severity	Pretreatment- Posttreatment ( 6 weeks later)
Primary	visual analog scale	Neck pain severity	Pretreatment-Posttreatment (6 weeks later)
Primary	Baseline Dolorimeter	pressure pain threshold	pretreatment- Posttreatment ( 6 weeks later)
Primary	Clinical data questionnaire	clinical data	pretreatment- Posttreatment ( 6 weeks later)
Secondary	Short form-36	quality of life	pretreatment - Post treatment (6 weeks later)
Secondary	MIDAS	Migraine Disability Assessment Scale (not score scale It describes the total of 3-month headache )	Pretreatment
Secondary	Neck Disability Index	questionnaire to assess neck pain related disability	pretreatment - Post treatment (6 weeks later)