MigraineNCT04185714
THE EFFECTS OF KINESIO®TAPING IN PATIENTS WITH MIGRAINE
A study testing Kinesiotaping in people with Migraine and Pain, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- What is being tested?
- Kinesiotaping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 30 Sep 2020
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Kinesiotaping, Placebo taping
- Keywords
- Episodic Migraine, Kinesiotape, Pain, Physiotherapy, Disability, Pressure Pain Threshold, Quality of Life
- Medical subject headings
- Migraine Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingOther
Also called exercise, sham taping
Kinesiotaping (KT) is an approach that supports injured muscles and joints and helps relieve pain.
Placebo tapingOther
sham taping
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group will be applied Kinesotaping , exercise programme will be given. Receives: Other: Kinesiotaping |
| Control group | No intervention | Exercise programme will be given. |
| Placebo group | Placebo comparator | Sham taping will be applied, exercise programme will be given. Receives: Other: Placebo taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
Headache pain severity
Measured: Pretreatment- Posttreatment ( 6 weeks later)
visual analog scale
Neck pain severity
Measured: Pretreatment-Posttreatment (6 weeks later)
Baseline Dolorimeter
pressure pain threshold
Measured: pretreatment- Posttreatment ( 6 weeks later)
Clinical data questionnaire
clinical data
Measured: pretreatment- Posttreatment ( 6 weeks later)
Secondary outcomes (3)
Short form-36
quality of life
Measured: pretreatment - Post treatment (6 weeks later)
MIDAS
Migraine Disability Assessment Scale (not score scale It describes the total of 3-month headache )
Measured: Pretreatment
Neck Disability Index
questionnaire to assess neck pain related disability
Measured: pretreatment - Post treatment (6 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Jan 2020
- Primary completion30 Mar 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Kınacı, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185714
- Sponsor's protocol ID
- 10840098-604.01.1
- Status last verified
- May 2021
- First submitted
- 25 Nov 2019
- Last updated
- 13 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Biber EK, Polat B. Effects of kinesiotaping combined with physical therapy in patients with migraine-associated neck pain: a randomized controlled study. BMC Musculoskelet Disord. 2025 Oct 23;26(1):990. doi: 10.1186/s12891-025-08985-2.
PubMed 41131499
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04185714
- Acronym / sponsor ID
- 10840098-604.01.1
- Keywords
- Episodic Migraine, Kinesiotape, Pain, Physiotherapy, Disability, Pressure Pain Threshold, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 4 Dec 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: KinesiotapingExperimental group will be applied Kinesotaping , exercise programme will be given. |
| Control group | No intervention | –Exercise programme will be given. |
| Placebo group | Placebo comparator | Other: Placebo tapingSham taping will be applied, exercise programme will be given. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- other headache disorders
- disc disorders,
- systemic rheumatic disease, fibromyalgia pain syndrome, myofascial pain syndrome,
- temporamandibular joint dysfunction,
- pregnancy,
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 |
|---|---|---|
| KinesiotapingAlso: exercise, sham tapingKinesiotaping (KT) is an approach that supports injured muscles and joints and helps relieve pain. | Other | Experimental group |
| Placebo tapingsham taping | Other | Placebo group |
Primary outcome
visual analog scale
Time frame: Pretreatment- Posttreatment ( 6 weeks later)
Headache pain severity
visual analog scale
Time frame: Pretreatment-Posttreatment (6 weeks later)
Neck pain severity
Baseline Dolorimeter
Time frame: pretreatment- Posttreatment ( 6 weeks later)
pressure pain threshold
Clinical data questionnaire
Time frame: pretreatment- Posttreatment ( 6 weeks later)
clinical data
3 secondary outcomes
Short form-36
Time frame: pretreatment - Post treatment (6 weeks later)
MIDAS
Time frame: Pretreatment
Neck Disability Index
Time frame: pretreatment - Post treatment (6 weeks later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Derived from this study: PubMed 41131499Biber EK, Polat B. Effects of kinesiotaping combined with physical therapy in patients with migraine-associated neck pain: a randomized controlled study. BMC Musculoskelet Disord. 2025 Oct 23;26(1):990. doi: 10.1186/s12891-025-08985-2.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping in people with Migraine and Pain, run by Medipol 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 8 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: finished, as of the sponsor's last update on 13 May 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
visual analog scale (time frame: Pretreatment- Posttreatment ( 6 weeks later)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04185714, which also lists 1 linked publication.
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 13 May 2021.