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Clinical Trials/NCT04185714
NCT04185714
Completed
Not Applicable

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

Medipol University1 site in 1 country60 target enrollmentJanuary 1, 2020
ConditionsMigrainePain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Migraine
Sponsor
Medipol University
Enrollment
60
Locations
1
Primary Endpoint
Baseline Dolorimeter
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
September 30, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medipol University
Responsible Party
Principal Investigator
Principal Investigator

Esra Kınacı

Research Asistant

Medipol University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Baseline Dolorimeter

Time Frame: pretreatment- Posttreatment ( 6 weeks later)

pressure pain threshold

Clinical data questionnaire

Time Frame: pretreatment- Posttreatment ( 6 weeks later)

clinical data

visual analog scale

Time Frame: Pretreatment-Posttreatment (6 weeks later)

Neck pain severity

Secondary Outcomes

  • Short form-36(pretreatment - Post treatment (6 weeks later))
  • MIDAS(Pretreatment)
  • Neck Disability Index(pretreatment - Post treatment (6 weeks later))

Study Sites (1)

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