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NCT Number: NCT07477483

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.

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Key information

Conditions

Tension Type Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases Tension-Type Headache

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan Univesity Faculty of Health Sciences

Konya, 42090, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ayça Seda Yıldırımer, PT

CONTACT

[email protected]

+90 507 409 08 99

Neslihan Altuntaş Yılmaz, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Use of hormone therapy.
  • History of cervical surgery.
  • History of neurological disease.
  • Pregnancy.
  • Inability to understand questionnaire forms.
  • Failure to attend treatment sessions.

Treatment and study plan

Manuel Therapy

Procedure

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.

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)

    Time frame: Baseline and after 2 weeks of treatment

    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.

  2. Quality of Life (SF-12)

    Time frame: Baseline and after 2 weeks of treatment

    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.

  3. Pressure Pain Threshold

    Time frame: Baseline and after 2 weeks of treatment

    Pressure pain threshold will be measured using a digital algometer applied to the pericranial muscles. The minimum pressure that induces pain will be recorded.

  4. Cervical Range of Motion

    Time frame: Baseline and after 2 weeks of treatment

    Cervical range of motion will be assessed using a universal goniometer to evaluate cervical flexion, extension, lateral flexion, and rotation movements.

  5. Executive Function (Trail Making Test Part B)

    Time frame: Baseline and after 2 weeks of treatment

    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.

  6. Depression Severity (Beck Depression Inventory)

    Time frame: Baseline and after 2 weeks of treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayça Seda Yıldırımer, PT, MSc

CONTACT

[email protected]

+90 507 409 08 99

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

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

Acronym: TTH-MT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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