NCT07411820

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 9, 2026

Last Update Submit

February 9, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Headache Intensity

    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

    Measurement Tool: Headache Diary Number of headache days per month recorded by participants.

    Baseline, 4 weeks post-intervention, 1-month follow-up

  • Headache Impact

    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 Outcomes (2)

  • Pressure Pain Threshold (PPT)

    Baseline and 4 weeks post-intervention

  • Craniovertebral Angle (CVA)

    Baseline and 4 weeks post-intervention

Study Arms (2)

Postural Correction and Suboccipital Muscle Inhibition

ACTIVE COMPARATOR

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.

Other: Postural Correction and SMI Program

Kinesio Taping + Postural Correction and SMI

EXPERIMENTAL

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.

Other: Kinesio Taping Combined with Postural Correction and SMI

Interventions

Deep neck flexor exercises, suboccipital muscle inhibition, and ergonomic education performed twice weekly for four weeks.

Postural Correction and Suboccipital Muscle Inhibition

Same as the control program with addition of Kinesio Taping to cervical and trapezius muscles.

Kinesio Taping + Postural Correction and SMI

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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°

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deraya university, faculty of physical therapy

Minya, Menia Governorate, Egypt

Location

Related Publications (8)

  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • de Tommaso, M., & Fernández-de-Las-Penas, C. (2016). Tension type headache. Current Rheumatology Reviews, 12(2), 127-139. DOI: 10.2174/1573397112666151231113625

    BACKGROUND

MeSH Terms

Conditions

Headache Disorders

Interventions

Medicare Part B

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MedicareMedical AssistancePublic AssistanceFinancing, GovernmentFinancing, OrganizedEconomicsHealth Care Economics and OrganizationsInsurance, HealthInsuranceLegislation as TopicSocial Control, Formal

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 17, 2026

Study Start

February 10, 2025

Primary Completion

May 10, 2025

Study Completion

July 1, 2025

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations