Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:39 AM
Study NCT ID:
NCT07411820
Status:
COMPLETED
Last Update Posted:
2026-02-17
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Kinesio Taping Combined With Postural Correction on Improving Tension-Type Headache Among University Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020773', 'term': 'Headache Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016345', 'term': 'Medicare Part B'}], 'ancestors': [{'id': 'D006278', 'term': 'Medicare'}, {'id': 'D008483', 'term': 'Medical Assistance'}, {'id': 'D011632', 'term': 'Public Assistance'}, {'id': 'D005380', 'term': 'Financing, Government'}, {'id': 'D005381', 'term': 'Financing, Organized'}, {'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D007348', 'term': 'Insurance, Health'}, {'id': 'D007341', 'term': 'Insurance'}, {'id': 'D007878', 'term': 'Legislation as Topic'}, {'id': 'D012926', 'term': 'Social Control, Formal'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will be blinded to the specific purpose of each intervention and will not be informed of group assignment. Training sessions will be scheduled separately to minimize awareness.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Fifty-two participants will be randomly assigned to two parallel groups. The experimental group will receive Kinesio Taping in addition to postural correction and SMI, while the control group will receive postural correction and SMI only. Both groups will undergo two sessions per week for four weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache Intensity', 'timeFrame': 'Baseline, 4 weeks post-intervention, 1-month follow-up', 'description': 'Measurement Tool: Visual Analog Scale (VAS) / Numeric Pain Rating Scale Self-reported headache pain intensity (0-10 scale).'}, {'measure': 'Headache Frequency', 'timeFrame': 'Baseline, 4 weeks post-intervention, 1-month follow-up', 'description': 'Measurement Tool: Headache Diary Number of headache days per month recorded by participants.'}, {'measure': 'Headache Impact', 'timeFrame': 'Baseline, 4 weeks post-intervention, 1-month follow-up', 'description': 'Measurement Tool: Headache Impact Test (HIT-6)\n\nDescription: Assesses the effect of headaches on daily life and function.'}], 'secondaryOutcomes': [{'measure': 'Pressure Pain Threshold (PPT)', 'timeFrame': 'Baseline and 4 weeks post-intervention', 'description': 'Measurement Tool: Pressure Algometer Description: Measures pericranial muscle tenderness.'}, {'measure': 'Craniovertebral Angle (CVA)', 'timeFrame': 'Baseline and 4 weeks post-intervention', 'description': 'Measurement Tool: Goniometer / Digital Photogrammetry\n\nDescription: Quantifies forward head posture; increased angle indicates improvement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Headache Disorders', 'Forward Head Posture', 'Muscle Tension']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': 'de Tommaso, M., & Fernández-de-Las-Penas, C. (2016). Tension type headache. Current Rheumatology Reviews, 12(2), 127-139. DOI: 10.2174/1573397112666151231113625'}]}, 'descriptionModule': {'briefSummary': "This study aims to evaluate the effectiveness of combining Kinesio Taping (KT) with postural correction exercises and suboccipital muscle inhibition (SMI) in managing tension-type headaches (TTH) among university students. The intervention's impact on headache intensity, frequency, and functional limitations will be compared with a control group performing postural correction and SMI alone.", 'detailedDescription': '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.\n\nKinesio Taping (KT) has been proposed as an adjunct that enhances proprioception, reduces muscle tension, and supports cervical alignment.\n\nThis 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:\n\nGroup A (Control): Postural correction + SMI Group B (Experimental): Kinesio Taping + Postural correction + SMI\n\nBoth groups will receive two treatment sessions per week for 4 weeks.\n\nAssessments 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* University students aged 18-25 years\n* Diagnosed with tension-type headache per ICHD-3 criteria\n* At least 10 headache episodes per month for \\>3 months\n* Pericranial muscle tenderness (suboccipital, temporalis, upper trapezius)\n* Craniovertebral angle \\< 50°\n\nExclusion Criteria:\n\n* Migraine or cluster headaches\n* Recent neck trauma or surgery\n* Skin allergy or sensitivity to tape\n* Current use of medications affecting pain perception Cervical radiculopathy or neurological deficits'}, 'identificationModule': {'nctId': 'NCT07411820', 'briefTitle': 'Effect of Kinesio Taping Combined With Postural Correction on Improving Tension-Type Headache Among University Students', 'organization': {'class': 'OTHER', 'fullName': 'Deraya University'}, 'officialTitle': 'Effect of Kinesio Taping Combined With Postural Correction on Improving Tension-Type Headache Among University Students', 'orgStudyIdInfo': {'id': 'DU-PT-KT-TTH-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Postural Correction and Suboccipital Muscle Inhibition', 'description': 'Participants will receive a postural correction program consisting of:\n\nDeep 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.', 'interventionNames': ['Other: Postural Correction and SMI Program']}, {'type': 'EXPERIMENTAL', 'label': 'Kinesio Taping + Postural Correction and SMI', 'description': 'Participants will receive the same postural correction program as the control group with the addition of Kinesio Taping:\n\nKinesio Tape applied to cervical spine and upper trapezius to enhance proprioception and reduce strain.\n\nTwo sessions per week for 4 weeks.', 'interventionNames': ['Other: Kinesio Taping Combined with Postural Correction and SMI']}], 'interventions': [{'name': 'Postural Correction and SMI Program', 'type': 'OTHER', 'description': 'Deep neck flexor exercises, suboccipital muscle inhibition, and ergonomic education performed twice weekly for four weeks.', 'armGroupLabels': ['Postural Correction and Suboccipital Muscle Inhibition']}, {'name': 'Kinesio Taping Combined with Postural Correction and SMI', 'type': 'OTHER', 'description': 'Same as the control program with addition of Kinesio Taping to cervical and trapezius muscles.', 'armGroupLabels': ['Kinesio Taping + Postural Correction and SMI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minya', 'state': 'Menia Governorate', 'country': 'Egypt', 'facility': 'Deraya university, faculty of physical therapy', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deraya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}