Tension Type HeadacheNCT06675019
The Effect of Manual Therapy Versus Kinesio Taping on Tension-type Headache in Jouf University Female Students
A study testing Manual therapy and Kinesio taping in people with Tension Type Headache, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Tension Type Headache
- What is being tested?
- Manual therapy and Kinesio taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2024to 15 Jan 2025
- 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 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy, Cairo University
Giza, Giza Governorate
About this study
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.
- Conditions
- Tension Type Headache
- Being tested
- Manual therapy, Kinesio taping, Control (Standard treatment)
- Keywords
- tension type headache, manual therapy, kinesio taping
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
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.
Kinesio tapingOther
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.
Control (Standard treatment)Other
The control group will just receive relaxation exercises three times per week, in addition to their medications as needed.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy | Experimental | Not described Receives: Other: Manual therapy |
| Kinesio taping | Experimental | Not described Receives: Other: Kinesio taping |
| Control group | Active comparator | Not described Receives: Other: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (2)
The 6-item headache questionnaire
The 6-item headache questionnaire will be examined before the intervention, after one month, and at the end intervention; it comprises six items (pain intensity, social functioning, role functioning, vitality, cognitive functioning, and psychological distress), each with five response alternatives. Never: 6 points, rarely: 8 points, sometimes: 10 points, very frequently: 11 points, and always: 13 points, with a total score ranging from 36 to 78 points.
Measured: 8 weeks
A headache diary
A headache diary will include recording the data at the end of the day to create a record of the clinical history of pain, including frequency, duration (hours per day), headache intensity (Visual Analogue Scale [VAS]: 0-10), and analgesic use.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start15 Nov 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension Type HeadacheStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rokaia Ali Zainelabedeen Mohamed Toson, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675019
- Sponsor's protocol ID
- 2024-92
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Manual Therapy Versus Kinesio Taping on Tension-type Headache in Jouf University Female Students
- ClinicalTrials.gov ID
- NCT06675019
- Acronym / sponsor ID
- 2024-92
- Conditions
- Tension Type Headache
- Keywords
- tension type headache, manual therapy, kinesio taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 5 Nov 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual therapy | Experimental | Other: Manual therapy |
| Kinesio taping | Experimental | Other: Kinesio taping |
| Control group | Active comparator | Other: Control (Standard treatment) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Manual therapyManual 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. | Other | Manual therapy |
| Kinesio tapingKinesio 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. | Other | Kinesio taping |
| Control (Standard treatment)The control group will just receive relaxation exercises three times per week, in addition to their medications as needed. | Other | Control group |
Primary outcome
Visual Analouge Scale
Time frame: 8 weeks
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.
2 secondary outcomes
The 6-item headache questionnaire
Time frame: 8 weeks
A headache diary
Time frame: 8 weeks
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 24 Jan 2025.
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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 Manual therapy and Kinesio taping in people with Tension Type Headache, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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 24 Jan 2025. 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 Egypt. 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. 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 Analouge Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2025.