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Efficacy of Kinesio Taping in Tension Type Headache

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ClinicalTrials.gov Identifier: NCT03665142
Recruitment Status : Active, not recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
TOMRIS DUYMAZ, Istanbul Bilgi University

Brief Summary:

Aim: The purpose of this study was to investigate the efficacy of Kinesio taping on upper trapezius muscle on the reduction of pain and emotional state in the treatment of patients with tension type headache by acting on myofacial mechanoreceptors.

Methods: This study was conducted in 71 patients aged 30-45 years with tension type headache diagnosed. Patients were randomly divided into 2 groups. While KT and stretching exercises were performed in the study group, only the stretching exercise was performed for the control group. KT was applied 8 times in total for 4 weeks with 2 sessions per week. Stretching exercise was done in the morning, afternoon and evening 3 times every day for 4 weeks and 5 days of the week. After recording the demographic data of all the patients participating in the study, assessed the sensitivity of the right and left upper parts of the trapezius with algometer, pain intensity with visual analog scale (VAS), Beck depression and anxiety scale for emotional status before and after treatment. p < 0.05 was considered statistically significant.


Condition or disease Intervention/treatment Phase
Tension-Type Headache Other: Kinesio taping Other: Exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients were randomly divided into 2 groups. A randomized list is prepared in a computer environment by a statistician for randomization. In this list, the odd numbers for the control group and the KT group were given double numbers. The group identification is printed on sequentially numbered cards placed in sealed envelopes. After enrollment, the numbered envelope was opened by the patient and the blind investigator.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Kinesio Taping on Pain, Pain Threshold and Emotional Status in Tension Type Headache
Actual Study Start Date : April 5, 2018
Actual Primary Completion Date : June 10, 2018
Estimated Study Completion Date : September 25, 2018

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Arm Intervention/treatment
Experimental: Kinesio taping
In this study, Kinesio Tape Tex Gold® kinesio tape over lateral ankle (5cm*5m) is used. 36 participants were taped for the TTH.50-mm wide and 0.5-mm thick KT was applied to the upper trapezius muscle with one I-shaped tape. The tape was measured from the acromion to the hairline at the back, and the upper trapezius fibers were extended in the extended position, ie the cervical vertebrae were flexed to the opposite side and applied to the same side in the flexion and rotation position.
Other: Kinesio taping
Upper trapezius muscle stretching exercise with Kinesio taping (KT) was applied to the study group. KT was applied 8 times in total for 4 weeks with 2 sessions per week. Stretching exercise was done in the morning, afternoon and evening 3 times (repeated 10 times per set) every day for 4 weeks and 5 days of the week.

Placebo Comparator: Exercise
Upper trapezius muscle stretching exercise was applied to the control group.
Other: Exercise
Upper trapezius muscle stretching exercise was applied to the control group.




Primary Outcome Measures :
  1. Pain thershold [ Time Frame: 2 minute ]
    The algometer is a mechanical pressure device with a minimum diameter of 100 g and a pressure of 10 kg / cm2, with a spring-loaded cylinder with a rubber tip, a circle and a pressure surface of 1 cm2 in diameter, obtained in kg / cm2. Before measuring with the algometer, a pressure of approximately 4 kg was applied to the midpoint of the upper part of the trapezius muscle, which is the control point, with the pulp of the thumb of the hand. Then the force was applied to the same point, causing pain to separate the patient's sense of pressure and pain sensation. This process has been repeated several times. Measurements with an algometer were made at a rate of 1 kg per second. The measurements were interrupted for at least 15-20 seconds. Three measurements were made at these 2 sensitive points and the average of the measurements was recorded.


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: 1 minutes ]
    Visual Analog Scale (VAS) is used to convert some numerical values, such as pain, to numeric values. The two extremes of a 100 mm line are to be assessed on two extremes and the patient is asked to indicate on the line where the severity of the pain is appropriate by drawing a line or placing a point or pointing. The length of the distance from where the pain has never occurred to the point the patient has marked indicates the pain of the patient

  2. Questionnaire [ Time Frame: 15 minutes ]
    Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI) developed by Aron T. Beck in 1961, Turkish validity and reliability were done by Hisli N. Emotional state assessment scale that measures the characteristic attitude and depression symptoms. The application takes about 10-15 minutes to complete. It is designed for people aged 13 and over. Scoring and evaluation of scales is easy. The total number of points counted from each four-sentence sentence group is found. For depression scale; 0-9: Normal level, 10-16: Mild depression, 17-29: Moderate depression, 30-63: Indicates severe depression. For anxiety scale; Normal range between 0-7 points, mild anxiety between 8-15 points, middle anxiety between 16-25 points, and severe anxiety between 26-63 points



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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • between 30 and 45 years of age
  • who had a tension-type headache diagnosis
  • presence of tenderness points on the upper part of the trapezius
  • voluntary or written volunteers to participate in the study

Exclusion Criteria:

  • cervical area surgery and / or surgery, cervical trauma history
  • systemic disease targeting this area
  • moderate or excessive nausea and vomiting with headache
  • headache due to other causes (e.g., subarachnoid hemorrhage, cerebral hemorrhage, cerebral embolism, cerebral thrombosis, vascular malformation, arthritis, hypertension, or arteriosclerosis)
  • have used prophylactic headache medications in the last 3 months
  • neurological, mental, hemorrhagic disease, allergy, serious heart, liver, kidney and other organ deficiencies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665142


Locations
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Turkey
Tomris Duymaz
Istanbul, Turkey, 34440
Sponsors and Collaborators
Istanbul Bilgi University
Investigators
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Principal Investigator: TOMRIS DUYMAZ Istanbul Bilgi University

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Responsible Party: TOMRIS DUYMAZ, Principal Investigator, Istanbul Bilgi University
ClinicalTrials.gov Identifier: NCT03665142     History of Changes
Other Study ID Numbers: IBU2018
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by TOMRIS DUYMAZ, Istanbul Bilgi University:
Tension-Type Headache
Kinesio Tape
Pain

Additional relevant MeSH terms:
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Tension-Type Headache
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases