Tension Type HeadacheTTH-MTNCT07477483
Effect of Manuel Therapy on Tension Type Headache in Menopausal and Premenopasual Women
A study testing Manuel Therapy in people with Tension Type Headache, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effectiveness of manual therapy in women with tension-type headache and to compare treatment outcomes between menopausal and premenopausal women. Hormonal changes occurring during menopause may influence pain perception and headache characteristics. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Tension Type Headache
- What is being tested?
- Manuel Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged between 45 and 65 years.
- Diagnosis of tension-type headache.
- Premenopausal or menopausal status.
- HIT-6 score of 49 or higher.
- Willingness to participate in the study.
Who cannot join
- Use of hormone therapy.
- History of cervical surgery.
- History of neurological disease.
- Pregnancy.
- Inability to understand questionnaire forms.
- Failure to attend treatment sessions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Necmettin Erbakan Univesity Faculty of Health Sciences
Konya, Konya, 42090
Ayça Seda Yıldırımer, PT, +90 507 409 08 99, aycaseda29@gmail.com
Neslihan Altuntaş Yılmaz, PhD
About this study
Official title: Comparison of the Effect of Manuel Therapy on Tension Type Headache in Menopausal and Premenopasual Women
This study aims to investigate the effectiveness of manual therapy in women with tension-type headache and to compare treatment outcomes between menopausal and premenopausal women. Hormonal changes occurring during menopause may influence pain perception and headache characteristics.
Participants diagnosed with tension-type headache will receive manual therapy interventions. Headache intensity, headache-related disability, pressure pain threshold, cervical range of motion, sleep quality, and quality of life will be evaluated before and after treatment using validated assessment tools. The results are expected to contribute to physiotherapy approaches in women experiencing tension-type headache during different hormonal periods.
Read the detailed description
Tension-type headache (TTH) is the most prevalent type of primary headache and is characterized by bilateral, pressing, or tightening pain of mild to moderate intensity. It has a considerable impact on daily activities, psychological status, sleep quality, and overall quality of life. Hormonal changes occurring during the menopausal transition may influence pain perception, musculoskeletal sensitivity, and headache characteristics. Therefore, investigating treatment responses in different hormonal periods may provide valuable clinical insights.
The aim of this study is to investigate and compare the effectiveness of manual therapy applications in menopausal and premenopausal women with tension-type headache. The study will include women diagnosed with tension-type headache who meet the inclusion criteria. Participants will be evaluated before and after the intervention period.
Manual therapy interventions including soft tissue techniques, cervical mobilization, and therapeutic exercises will be applied. Outcome measures will include headache intensity assessed with the Visual Analog Scale (VAS), headache-related disability evaluated using the Headache Impact Test (HIT-6), pressure pain threshold measured by algometer, cervical range of motion assessed using a goniometer, sleep quality evaluated with the Pittsburgh Sleep Quality Index (PSQI), and health-related quality of life measured with the Short Form-36 (SF-36).
The results of this study are expected to provide evidence regarding the role of manual therapy in the management of tension-type headache and contribute to physiotherapy practices targeting women in different hormonal stages.
- Conditions
- Tension Type Headache
- Being tested
- Manuel Therapy
- Keywords
- Manuel Therapy, Tension Type Headache, Women, Menopause, Premenopause, Physiotherapy
- 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.
Manuel TherapyProcedure or surgery
Participants diagnosed with tension-type headache will receive manual therapy interventions including cervical mobilization, soft tissue techniques, and suboccipital muscle relaxation. Treatments will be applied by a physiotherapist during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal Women With Tension-Type Headache | Experimental | Premenopausal women diagnosed with tension-type headache who will receive manual therapy interventions during the study. Receives: Procedure: Manuel Therapy |
| Menopausal Women With Tension-Type Headache | Experimental | Menopausal women diagnosed with tension-type headache who will receive manual therapy interventions during the study. Receives: Procedure: Manuel Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain İntensity (Visual Analog Scale - VAS)
Pain intensity will be assesed using the Visual Analog Scale (VAS). Participants will rate their pain on a 10 cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain)
Measured: Baseline and after 2 weeks of treatment
Headache İmpact (Headache İmpact Test - HİT-6)
Headache-related disability will be evaluted using the Headache İmpact Test (HİT-6). This questionnaire assesses the impact of headaches on daily functioning, social activities and overall quality of life.
Measured: Baseline and after 2 weeks of treatment
Secondary outcomes (6)
Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)
Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), a self-reported questionnaire that assesses sleep quality and disturbances over the previous month. Higher scores indicate poorer sleep quality.
Measured: Baseline and after 2 weeks of treatment
Quality of Life (SF-12)
Health-related quality of life will be assessed using the SF-12 Short Form Health Survey. The SF-12 evaluates physical and mental components of health-related quality of life. Higher scores indicate better health-related quality of life.
Measured: Baseline and after 2 weeks of treatment
Pressure Pain Threshold
Pressure pain threshold will be measured using a digital algometer applied to the pericranial muscles. The minimum pressure that induces pain will be recorded.
Measured: Baseline and after 2 weeks of treatment
Cervical Range of Motion
Cervical range of motion will be assessed using a universal goniometer to evaluate cervical flexion, extension, lateral flexion, and rotation movements.
Measured: Baseline and after 2 weeks of treatment
Executive Function (Trail Making Test Part B)
Executive function and cognitive flexibility will be assessed using the Trail Making Test Part B (TMT-B). The test evaluates visual attention, processing speed, and task-switching ability. The time required to complete the test will be recorded.
Measured: Baseline and after 2 weeks of treatment
Depression Severity (Beck Depression Inventory)
Depressive symptoms will be assessed using the Beck Depression Inventory (BDI), a 21-item self-report questionnaire designed to measure the severity of depressive symptoms.
Measured: Baseline and after 2 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Oct 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
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 Necmettin Erbakan 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be divided into two groups: premenopausal women and menopausal women with tension type headache. Both groups will receive manuel therapy interventions and the outcomes will be compared
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Seda, Necmettin Erbakan University
- Investigators
- Neslihan Altuntaş Yılmaz, PhD, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477483
- Sponsor's protocol ID
- TTH_MT_MENOPAUSE_2026
- Acronym
- TTH-MT
- Status last verified
- May 2026
- First submitted
- 12 Mar 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: İndividual participant data collected during this study will not be publicly shared. The data will be used only for the purposes of this research and will be stored securely bu the research team.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Manuel Therapy on Tension Type Headache in Menopausal and Premenopasual Women
- ClinicalTrials.gov ID
- NCT07477483
- Acronym / sponsor ID
- TTH-MT / TTH_MT_MENOPAUSE_2026
- Conditions
- Tension Type Headache
- Keywords
- Manuel Therapy, Tension Type Headache, Women, Menopause, Premenopause, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 17 Mar 2026 (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.
This study aims to investigate the effectiveness of manual therapy in women with tension-type headache and to compare treatment outcomes between menopausal and premenopausal women. Hormonal changes occurring during menopause may influence pain perception and headache characteristics.
Participants diagnosed with tension-type headache will receive manual therapy interventions. Headache intensity, headache-related disability, pressure pain threshold, cervical range of motion, sleep quality, and quality of life will be evaluated before and after treatment using validated assessment tools. The results are expected to contribute to physiotherapy approaches in women experiencing tension-type headache during different hormonal periods.
Detailed description
Tension-type headache (TTH) is the most prevalent type of primary headache and is characterized by bilateral, pressing, or tightening pain of mild to moderate intensity. It has a considerable impact on daily activities, psychological status, sleep quality, and overall quality of life. Hormonal changes occurring during the menopausal transition may influence pain perception, musculoskeletal sensitivity, and headache characteristics. Therefore, investigating treatment responses in different hormonal periods may provide valuable clinical insights.
The aim of this study is to investigate and compare the effectiveness of manual therapy applications in menopausal and premenopausal women with tension-type headache. The study will include women diagnosed with tension-type headache who meet the inclusion criteria. Participants will be evaluated before and after the intervention period.
Manual therapy interventions including soft tissue techniques, cervical mobilization, and therapeutic exercises will be applied. Outcome measures will include headache intensity assessed with the Visual Analog Scale (VAS), headache-related disability evaluated using the Headache Impact Test (HIT-6), pressure pain threshold measured by algometer, cervical range of motion assessed using a goniometer, sleep quality evaluated with the Pittsburgh Sleep Quality Index (PSQI), and health-related quality of life measured with the Short Form-36 (SF-36).
The results of this study are expected to provide evidence regarding the role of manual therapy in the management of tension-type headache and contribute to physiotherapy practices targeting women in different hormonal stages.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be divided into two groups: premenopausal women and menopausal women with tension type headache. Both groups will receive manuel therapy interventions and the outcomes will be compared
| Arm | Type | Receives |
|---|---|---|
| Premenopausal Women With Tension-Type Headache | Experimental | Procedure: Manuel TherapyPremenopausal women diagnosed with tension-type headache who will receive manual therapy interventions during the study. |
| Menopausal Women With Tension-Type Headache | Experimental | Procedure: Manuel TherapyMenopausal women diagnosed with tension-type headache who will receive manual therapy interventions during the study. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female participants aged between 45 and 65 years.
- Diagnosis of tension-type headache.
- Premenopausal or menopausal status.
- HIT-6 score of 49 or higher.
- Willingness to participate in the study.
Key exclusion criteria (6 listed)
- Use of hormone therapy.
- History of cervical surgery.
- History of neurological disease.
- Pregnancy.
- Inability to understand questionnaire forms.
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 |
|---|---|---|
| Manuel TherapyParticipants diagnosed with tension-type headache will receive manual therapy interventions including cervical mobilization, soft tissue techniques, and suboccipital muscle relaxation. Treatments will be applied by a physiotherapist during the study period. | Procedure or surgery | Menopausal Women With Tension-Type Headache, Premenopausal Women With Tension-Type Headache |
Primary outcome
Pain İntensity (Visual Analog Scale - VAS)
Time frame: Baseline and after 2 weeks of treatment
Pain intensity will be assesed using the Visual Analog Scale (VAS). Participants will rate their pain on a 10 cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain)
Headache İmpact (Headache İmpact Test - HİT-6)
Time frame: Baseline and after 2 weeks of treatment
Headache-related disability will be evaluted using the Headache İmpact Test (HİT-6). This questionnaire assesses the impact of headaches on daily functioning, social activities and overall quality of life.
6 secondary outcomes
Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)
Time frame: Baseline and after 2 weeks of treatment
Quality of Life (SF-12)
Time frame: Baseline and after 2 weeks of treatment
Pressure Pain Threshold
Time frame: Baseline and after 2 weeks of treatment
Cervical Range of Motion
Time frame: Baseline and after 2 weeks of treatment
Executive Function (Trail Making Test Part B)
Time frame: Baseline and after 2 weeks of treatment
Depression Severity (Beck Depression Inventory)
Time frame: Baseline and after 2 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No. İndividual participant data collected during this study will not be publicly shared. The data will be used only for the purposes of this research and will be stored securely bu the research team.
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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.
Neslihan Altuntaş Yılmaz, PhD principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manuel Therapy in people with Tension Type Headache, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 May 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayça Seda Yıldırımer, PT, MSc (+90 507 409 08 99, aycaseda29@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain İntensity (Visual Analog Scale - VAS) (time frame: Baseline and after 2 weeks of treatment). The study lists 2 primary outcomes in all. 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 20 May 2026.