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Recruiting NCT07477483

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

No phase Interventional Tension Type Headache

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Manuel Therapy.
Who it may be relevant to
Registry conditions: Tension Type Headache. Basic parameters: 45 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure Manuel Therapy
    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 outcome measures

  • Pain İntensity (Visual Analog Scale - VAS) [Time frame: Baseline and after 2 weeks of treatment]
  • Headache İmpact (Headache İmpact Test - HİT-6) [Time frame: Baseline and after 2 weeks of treatment]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Necmettin Erbakan Univesity Faculty of Health Sciences — Konya

Identifiers

NCT: NCT07477483 · TTH_MT_MENOPAUSE_2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗