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Effect of Manuel Therapy on Tension Type Headache in Menopausal and Premenopasual Women

Comparison of the Effect of Manuel Therapy on Tension Type Headache in Menopausal and Premenopasual Women

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07477483
Acronym
TTH-MT
Enrollment
50
Registered
2026-03-17
Start date
2025-10-01
Completion date
2026-05-01
Last updated
2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tension Type Headache

Keywords

Manuel Therapy, Tension Type Headache, Women, Menopause, Premenopause, Physiotherapy

Brief 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. 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.

Interventions

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.

Sponsors

Necmettin Erbakan University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

This study is an open-label study. No masking will be applied to participants, care providers or investigators

Intervention 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

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Women aged between 45 and 65 years Diagnosed with tension-type headache Premenopausal or menopausal status HIT-6 score ≥ 49 Willing to participate in the study

Exclusion criteria

Use of hormonal therapy History of cervical surgery History of neurological disease Pregnancy Inability to understand questionnaires Failure to attend treatment sessions

Design outcomes

Primary

MeasureTime frameDescription
Pain İntensity (Visual Analog Scale - VAS)Baseline and after 2 weeks of treatmentPain 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)Baseline and after 2 weeks of treatmentHeadache-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.

Secondary

MeasureTime frameDescription
Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)Baseline and after 2 weeks of treatmentSleep 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.
Quality of Life (SF-36)Baseline and after 2 weeks of treatmentHealth-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36), which evaluates physical and mental health across eight domains. Higher scores indicate better quality of life.
Pressure Pain ThresholdBaseline and after 2 weeks of treatmentPressure pain threshold will be measured using a digital algometer applied to the pericranial muscles. The minimum pressure that induces pain will be recorded.
Cervical Range of MotionBaseline and after 2 weeks of treatmentCervical range of motion will be assessed using a universal goniometer to evaluate cervical flexion, extension, lateral flexion, and rotation movements.
Executive Function (Trail Making Test Part B)Baseline and after 2 weeks of treatmentExecutive 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.
Depression Severity (Beck Depression Inventory)Baseline and after 2 weeks of treatmentDepressive symptoms will be assessed using the Beck Depression Inventory (BDI), a 21-item self-report questionnaire designed to measure the severity of depressive symptoms.

Countries

Turkey (Türkiye)

Contacts

CONTACTAyça Seda Yıldırımer, PT, MSc
aycaseda29@gmail.com+90 507 409 08 99
PRINCIPAL_INVESTIGATORNeslihan Altuntaş Yılmaz, PhD

Necmettin Erbakan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026