THE EFFECTS OF KINESIO®TAPING IN PATIENTS WITH MIGRAINE
Primary Purpose
Migraine, Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiotaping
Placebo taping
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring Episodic Migraine, Kinesiotape, Pain, Physiotherapy, Disability, Pressure Pain Threshold, Quality of Life
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.
Sites / Locations
- Duzce University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Placebo Comparator
Arm Label
Experimental group
Control group
Placebo group
Arm Description
Experimental group will be applied Kinesotaping , exercise programme will be given.
Exercise programme will be given.
Sham taping will be applied, exercise programme will be given.
Outcomes
Primary Outcome Measures
visual analog scale
Headache pain severity
visual analog scale
Neck pain severity
Baseline Dolorimeter
pressure pain threshold
Clinical data questionnaire
clinical data
Secondary Outcome Measures
Short form-36
quality of life
MIDAS
Migraine Disability Assessment Scale (not score scale It describes the total of 3-month headache )
Neck Disability Index
questionnaire to assess neck pain related disability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04185714
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Pain
Keywords
Episodic Migraine, Kinesiotape, Pain, Physiotherapy, Disability, Pressure Pain Threshold, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental group will be applied Kinesotaping , exercise programme will be given.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Exercise programme will be given.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Sham taping will be applied, exercise programme will be given.
Intervention Type
Other
Intervention Name(s)
Kinesiotaping
Other Intervention Name(s)
exercise, sham taping
Intervention Description
Kinesiotaping (KT) is an approach that supports injured muscles and joints and helps relieve pain.
Intervention Type
Other
Intervention Name(s)
Placebo taping
Intervention Description
sham taping
Primary Outcome Measure Information:
Title
visual analog scale
Description
Headache pain severity
Time Frame
Pretreatment- Posttreatment ( 6 weeks later)
Title
visual analog scale
Description
Neck pain severity
Time Frame
Pretreatment-Posttreatment (6 weeks later)
Title
Baseline Dolorimeter
Description
pressure pain threshold
Time Frame
pretreatment- Posttreatment ( 6 weeks later)
Title
Clinical data questionnaire
Description
clinical data
Time Frame
pretreatment- Posttreatment ( 6 weeks later)
Secondary Outcome Measure Information:
Title
Short form-36
Description
quality of life
Time Frame
pretreatment - Post treatment (6 weeks later)
Title
MIDAS
Description
Migraine Disability Assessment Scale (not score scale It describes the total of 3-month headache )
Time Frame
Pretreatment
Title
Neck Disability Index
Description
questionnaire to assess neck pain related disability
Time Frame
pretreatment - Post treatment (6 weeks later)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Duzce University
City
Düzce
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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THE EFFECTS OF KINESIO®TAPING IN PATIENTS WITH MIGRAINE
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