Tension-Type HeadacheNCT03665142
Efficacy of Kinesio Taping in Tension Type Headache
A study testing Kinesio taping and Exercise in people with Tension-Type Headache, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Kinesio taping and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2018to 25 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Kinesio Taping on Pain, Pain Threshold and Emotional Status in Tension Type Headache
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.
Read the detailed description
Participants This study was performed with 71 patients diagnosed as tension type headache. The study was conducted with patients at the Florence Nightingale Hospital between the ages of 30-45 who applied to the Neurology clinic. 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. Patients were included in the study, between 30 and 45 years of age, who had a tension headache diagnosis, presence of a tender points on the upper part of the trapezoid, voluntary or written volunteers to participate in the study. Exclusion criteria include 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.
Interventions Upper trapezius muscle stretching exercise with KT was applied to the study group, and upper trapezius muscle stretching exercise was applied to 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 (repeated 10 times per set) every day for 4 weeks and 5 days of the week.
KT application: 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. The band was fixed to the insertion site of the acromion in the initial resting position. The muscle was lengthened and the band was fixed with the initial skin shift, then the band was fixed to the origin of the hairline from the muscle fixed with 10% stretch. The tape was rubbed together with the muscle in the extended position.
Outcome measurements After recording the demographic data of all the patients participating in the study, the sensitivity of the right and left upper parts of the trapezius assessed with algometer, pain intensity with visual analog scale (VAS), Beck depression and anxiety scale for emotional status before and after treatment.
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 algo- rithm, 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.
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.
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.
- Conditions
- Tension-Type Headache
- Being tested
- Kinesio taping, Exercise
- Keywords
- Tension-Type Headache, Kinesio Tape, Pain
- Medical subject headings
- Tension-Type Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapingOther
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.
ExerciseOther
Upper trapezius muscle stretching exercise was applied to the control group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Kinesio taping |
| Exercise | Placebo comparator | Upper trapezius muscle stretching exercise was applied to the control group. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 minute
Secondary outcomes (2)
Pain intensity
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
Measured: 1 minutes
Questionnaire
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
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start5 Apr 2018
- Primary completion10 Jun 2018
- Study completion25 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TOMRIS DUYMAZ, Istanbul Bilgi University
- Investigators
- TOMRIS DUYMAZ, Principal investigator, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665142
- Sponsor's protocol ID
- IBU2018
- Status last verified
- Sep 2018
- First submitted
- 6 Sep 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Kinesio Taping on Pain, Pain Threshold and Emotional Status in Tension Type Headache
- ClinicalTrials.gov ID
- NCT03665142
- Acronym / sponsor ID
- IBU2018
- Conditions
- Tension-Type Headache
- Keywords
- Tension-Type Headache, Kinesio Tape, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 10 Jun 2018 (actual)
- Study completion
- 25 Sep 2018 (estimated)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants This study was performed with 71 patients diagnosed as tension type headache. The study was conducted with patients at the Florence Nightingale Hospital between the ages of 30-45 who applied to the Neurology clinic. 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. Patients were included in the study, between 30 and 45 years of age, who had a tension headache diagnosis, presence of a tender points on the upper part of the trapezoid, voluntary or written volunteers to participate in the study. Exclusion criteria include 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.
Interventions Upper trapezius muscle stretching exercise with KT was applied to the study group, and upper trapezius muscle stretching exercise was applied to 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 (repeated 10 times per set) every day for 4 weeks and 5 days of the week.
KT application: 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. The band was fixed to the insertion site of the acromion in the initial resting position. The muscle was lengthened and the band was fixed with the initial skin shift, then the band was fixed to the origin of the hairline from the muscle fixed with 10% stretch. The tape was rubbed together with the muscle in the extended position.
Outcome measurements After recording the demographic data of all the patients participating in the study, the sensitivity of the right and left upper parts of the trapezius assessed with algometer, pain intensity with visual analog scale (VAS), Beck depression and anxiety scale for emotional status before and after treatment.
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 algo- rithm, 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Kinesio taping | Experimental | Other: Kinesio tapingIn 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. |
| Exercise | Placebo comparator | Other: ExerciseUpper trapezius muscle stretching exercise was applied to the control group. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio tapingUpper 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. | Other | Kinesio taping |
| ExerciseUpper trapezius muscle stretching exercise was applied to the control group. | Other | Exercise |
Primary outcome
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.
2 secondary outcomes
Pain intensity
Time frame: 1 minutes
Questionnaire
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TOMRIS DUYMAZ principal investigator
Istanbul Bilgi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio taping and Exercise in people with Tension-Type Headache, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain thershold (time frame: 2 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.