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

NCT07477483 | Recruiting

• 1 other identifier: TTH_MT_MENOPAUSE_2026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Tension Type Headache

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Baseline and after 2 weeks of treatment

Secondary Outcomes (6)

• Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)

  Baseline and after 2 weeks of treatment

• Quality of Life (SF-12)

  Baseline and after 2 weeks of treatment

• Pressure Pain Threshold

  Baseline and after 2 weeks of treatment

• Cervical Range of Motion

  Baseline and after 2 weeks of treatment

• Executive Function (Trail Making Test Part B)

  Baseline and after 2 weeks of treatment

Study Arms (2)

Premenopausal Women With Tension-Type Headache

EXPERIMENTAL

Premenopausal women diagnosed with tension-type headache who will receive manual therapy interventions during the study.

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.

Procedure: Manuel Therapy

Interventions

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.

Menopausal Women With Tension-Type Headache; Premenopausal Women With Tension-Type Headache

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: Only female participant will be included in the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan Univesity Faculty of Health Sciences

Konya, Konya, 42090, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Neslihan Altuntaş Yılmaz, PhD

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayça Seda Yıldırımer, PT, MSc

CONTACT

+90 507 409 08 99; aycaseda29@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This study is an open-label study. No masking will be applied to participants, care providers or investigators
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: October 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)