NCT06675019

Brief Summary

Patients suffering from Tension Type Headache (TTH) report emotional and functional deficits (missing work, sleep disorders, emotional stability) and are susceptible to pharmaceutical abuse. Cervical muscle training, posture correction, spinal mobilization, and other physical therapy modalities may help alleviate symptoms. This study will aim to compare the effect of manual therapy and kinesio taping on tension-type headache.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

January 24, 2025

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 4, 2024

Last Update Submit

January 22, 2025

Conditions

Keywords

tension type headachemanual therapykinesio taping

Outcome Measures

Primary Outcomes (1)

  • Visual Analouge Scale

    The Visual Analogue Scale (VAS) will be used to assess the students' headache intensity before the intervention, after one month, and at the end intervention. VAS is used to transform some numerical values, such as pain, to numeric values. The two extremes of a 10 cm line are to be assessed on two extremes, and the patient is requested to indicate where the degree of the pain is appropriate by drawing a line or pointing.

    8 weeks

Secondary Outcomes (2)

  • The 6-item headache questionnaire

    8 weeks

  • A headache diary

    8 weeks

Study Arms (3)

Manual therapy

EXPERIMENTAL
Other: Manual therapy

Kinesio taping

EXPERIMENTAL
Other: Kinesio taping

Control group

ACTIVE COMPARATOR
Other: Control (Standard treatment)

Interventions

Manual therapy group: will have manual therapy and relaxation training three times per week in addition to their medications as needed. Manual therapy will include stretching exercises, strengthening exercises, soft tissue manipulation in the form of myofascial release and deep friction massage, and postural correction.

Manual therapy

Kinesio taping group: will have kinesio taping (KT), and relaxation exercises three times per week in addition to their medication as needed, One I-shaped tape was used to apply KT to the upper trapezius muscle that was 50 mm broad and 0.5 mm thick. The tape was measured from the acromion to the hairline in the back, and the upper trapezius fibers were stretched in the extended position, i.e., the cervical vertebrae were flexed to the opposite side and applied to the same side in the flexion and rotation positions. The band was secured to the acromion's insertion site in its first resting position. The muscle was lengthened, and the band was fixed with the initial skin shift, after which the band was fixed to the origin of the hairline from the muscle with a 10% stretch. The tape was massaged with the muscle in the extended position.

Kinesio taping

The control group will just receive relaxation exercises three times per week, in addition to their medications as needed.

Control group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Students between the ages of 18 and 25 will be enrolled in the study if they have tension type headache based on the IHS headache classification: A headache that occurs at least 15 days per month for more than 3 months (≥ 180 days per year) and lasts for hours or is continuous. The headache exhibits at least one of the following characteristics: 1. bilateral location, 2. pressing/tightening (non-pulsating) character, 3. mild or moderate intensity that is not exacerbated by routine physical activity such as walking or ascending stairs, and both of the following: 1. No more than one of photophobia, phonophobia, or mild nausea, and 2. No moderate to severe nausea or vomiting.

You may not qualify if:

  • Reumatoid arthritis, suspected malignancy, pregnancy, regular use of triptans, ergotamines, or opioids on ≥ 10 days/month or simple analgesics on ≥ 15 days/month for ≥ 3 months, or physical therapy treatment within 2 months prior to enrollment in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Giza Governorate, Egypt

Location

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physical Therapy

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 5, 2024

Study Start

November 15, 2024

Primary Completion

January 15, 2025

Study Completion

January 15, 2025

Last Updated

January 24, 2025

Record last verified: 2024-11

Locations