- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411820
Effect of Kinesio Taping Combined With Postural Correction on Improving Tension-Type Headache Among University Students
Study Overview
Status
Conditions
Detailed Description
Tension-type headache (TTH) is a common primary headache associated with muscular tension, poor posture, and psychological stress. Physiotherapy interventions including deep neck flexor exercises, suboccipital muscle inhibition (SMI), and postural education have been shown to reduce pain and improve posture.
Kinesio Taping (KT) has been proposed as an adjunct that enhances proprioception, reduces muscle tension, and supports cervical alignment.
This randomized controlled trial will recruit 52 university students aged 18-25 years diagnosed with frequent episodic TTH according to ICHD-3 criteria. Participants will be randomly assigned to two groups:
Group A (Control): Postural correction + SMI Group B (Experimental): Kinesio Taping + Postural correction + SMI
Both groups will receive two treatment sessions per week for 4 weeks.
Assessments will be performed at baseline, after 4 weeks of treatment, and at a 1-month follow-up using validated measures for pain, frequency, and posture.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Menia Governorate
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Minya, Menia Governorate, Egypt
- Deraya university, faculty of physical therapy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- University students aged 18-25 years
- Diagnosed with tension-type headache per ICHD-3 criteria
- At least 10 headache episodes per month for >3 months
- Pericranial muscle tenderness (suboccipital, temporalis, upper trapezius)
- Craniovertebral angle < 50°
Exclusion Criteria:
- Migraine or cluster headaches
- Recent neck trauma or surgery
- Skin allergy or sensitivity to tape
- Current use of medications affecting pain perception Cervical radiculopathy or neurological deficits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Postural Correction and Suboccipital Muscle Inhibition
Participants will receive a postural correction program consisting of: Deep neck flexor strengthening exercises (chin tucks, progressive resistance) Suboccipital muscle inhibition (manual pressure to release muscle tension) Ergonomic and postural education for studying and daily activities Two sessions per week for 4 weeks. |
Deep neck flexor exercises, suboccipital muscle inhibition, and ergonomic education performed twice weekly for four weeks.
|
|
Experimental: Kinesio Taping + Postural Correction and SMI
Participants will receive the same postural correction program as the control group with the addition of Kinesio Taping: Kinesio Tape applied to cervical spine and upper trapezius to enhance proprioception and reduce strain. Two sessions per week for 4 weeks. |
Same as the control program with addition of Kinesio Taping to cervical and trapezius muscles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Headache Intensity
Time Frame: Baseline, 4 weeks post-intervention, 1-month follow-up
|
Measurement Tool: Visual Analog Scale (VAS) / Numeric Pain Rating Scale Self-reported headache pain intensity (0-10 scale).
|
Baseline, 4 weeks post-intervention, 1-month follow-up
|
|
Headache Frequency
Time Frame: Baseline, 4 weeks post-intervention, 1-month follow-up
|
Measurement Tool: Headache Diary Number of headache days per month recorded by participants.
|
Baseline, 4 weeks post-intervention, 1-month follow-up
|
|
Headache Impact
Time Frame: Baseline, 4 weeks post-intervention, 1-month follow-up
|
Measurement Tool: Headache Impact Test (HIT-6) Description: Assesses the effect of headaches on daily life and function. |
Baseline, 4 weeks post-intervention, 1-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Pain Threshold (PPT)
Time Frame: Baseline and 4 weeks post-intervention
|
Measurement Tool: Pressure Algometer Description: Measures pericranial muscle tenderness.
|
Baseline and 4 weeks post-intervention
|
|
Craniovertebral Angle (CVA)
Time Frame: Baseline and 4 weeks post-intervention
|
Measurement Tool: Goniometer / Digital Photogrammetry Description: Quantifies forward head posture; increased angle indicates improvement. |
Baseline and 4 weeks post-intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Johansson, A. M., Vikingsson, H., & Varkey, E. (2017). The physiotherapist, an untapped resource for headaches: A survey of university students. European Journal of Physiotherapy, 20(1), 45-50. DOI: 10.1080/21679169.2017.1352023
- Repiso-Guardeño, A., Moreno-Morales, N., Armenta-Pendón, M. A., Rodríguez-Martínez, M. D. C., Pino-Lozano, R., & Armenta-Peinado, J. A. (2023). Physical therapy in TTH: A systematic review of randomized controlled trials. International Journal of Environmental Research and Public Health, 20(5), 4466. DOI: 10.3390/ijerph20054466
- Safiri, S., Kolahi, A.-A., Noori, M., Nejadghaderi, S. A., Aslani, A., Sullman, M. J. M., Farhoudi, M., Araj-Khodaei, M., Collins, G. S., Kaufman, J. S., et al. (2022). Burden of TTH in the Middle East and North Africa region, 1990-2019. Journal of Headache Pain, 23, 77. DOI: 10.1186/s10194-022-01445-5
- Bendtsen, L., Ashina, S., Moore, A., & Steiner, T. J. (2015). Muscles and their role in episodic TTH: Implications for treatment. European Journal of Pain, 20, 166-175. DOI: 10.1002/ejp.748
- Freitag, F. (2013). Managing and treating TTH. The Medical Clinics of North America, 97(2), 281-292. DOI: 10.1016/j.mcna.2012.12.003
- Headache Classification Committee of the International Headache Society (IHS). (2018). The International Classification of Headache Disorders, 3rd edition. Cephalalgia: An International Journal of Headache, 38(1), 1-211. DOI: 10.1177/0333102417738202
- Stovner, L. J., Hagen, K., Linde, M., & Steiner, T. J. (2022). The global prevalence of headache: An update, with analysis of the influences of methodological factors on prevalence estimates. Journal of Headache and Pain, 23, 34. DOI: 10.1186/s10194-022-01402-2
- de Tommaso, M., & Fernández-de-Las-Penas, C. (2016). Tension type headache. Current Rheumatology Reviews, 12(2), 127-139. DOI: 10.2174/1573397112666151231113625
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders
- Health Care Economics and Organizations
- Social Control, Formal
- Public Assistance
- Financing, Government
- Financing, Organized
- Economics
- Insurance, Health
- Insurance
- Medicare
- Legislation as Topic
- Medical Assistance
- Medicare Part B
Other Study ID Numbers
- DU-PT-KT-TTH-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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