NCT03665142

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2018

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

2 months

First QC Date

September 6, 2018

Last Update Submit

September 7, 2018

Conditions

Keywords

Tension-Type HeadacheKinesio TapePain

Outcome Measures

Primary Outcomes (1)

  • Pain thershold

    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.

    2 minute

Secondary Outcomes (2)

  • Pain intensity

    1 minutes

  • Questionnaire

    15 minutes

Study Arms (2)

Kinesio taping

EXPERIMENTAL

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

Exercise

PLACEBO COMPARATOR

Upper trapezius muscle stretching exercise was applied to the control group.

Other: Exercise

Interventions

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.

Kinesio taping

Upper trapezius muscle stretching exercise was applied to the control group.

Exercise

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tomris Duymaz

Istanbul, 34440, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tension-Type HeadachePain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • TOMRIS DUYMAZ

    Istanbul Bilgi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 6, 2018

First Posted

September 11, 2018

Study Start

April 5, 2018

Primary Completion

June 10, 2018

Study Completion

September 25, 2018

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations