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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorNecmettin Erbakan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female participants aged between 45 and 65 years.

Diagnosis of tension-type headache.

Premenopausal or menopausal status.

HIT-6 score of 49 or higher.

Disqualifiers

Use of hormone therapy.

History of cervical surgery.

History of neurological disease.

Pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Manuel Therapy

    Procedure/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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Premenopausal Women With Tension-Type HeadacheExperimental treatment 1 intervention
Group B: Menopausal Women With Tension-Type HeadacheExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline and after 2 weeks of treatment
2

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.

Time frame
Baseline and after 2 weeks of treatment

Secondary outcomes

1

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.

Time frame
Baseline and after 2 weeks of treatment
2

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.

Time frame
Baseline and after 2 weeks of treatment
3

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.

Time frame
Baseline and after 2 weeks of treatment
4

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.

Time frame
Baseline and after 2 weeks of treatment

Other outcomes

Sponsors and contacts

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