Clinical trial NCT04185714: THE EFFECTS OF KINESIO®TAPING IN PATIENTS WITH MIGRAINE
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Pain
Keywords: Episodic Migraine
Kinesiotape
Pain
Physiotherapy
Disability
Pressure Pain Threshold
Quality of Life
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: visual analog scale
timeFrame: Pretreatment- Posttreatment ( 6 weeks later)
measure: visual analog scale
timeFrame: Pretreatment-Posttreatment (6 weeks later)
measure: Baseline Dolorimeter
timeFrame: pretreatment- Posttreatment ( 6 weeks later)
measure: Clinical data questionnaire
timeFrame: pretreatment- Posttreatment ( 6 weeks later)
Secondary outcomes:
measure: Short form-36
timeFrame: pretreatment - Post treatment (6 weeks later)
measure: MIDAS
timeFrame: Pretreatment
measure: Neck Disability Index
timeFrame: pretreatment - Post treatment (6 weeks later)
Other outcomes:
Locations:
city: Düzce
country: Turkey
facility: Duzce University
Study officials:
References: