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The Effect of Foot Reflexology in Women With Migraine

9 de septiembre de 2026 actualizado por: Nurcan Contarli, Karabuk University

The Effect of Foot Reflexology on Pain, Disability, Anxiety, Kinesiophobia, and Postural Control in Women With Migraine

This prospective randomized controlled study aims to investigate the effects of foot massage on pain, anxiety, kinesiophobia, and postural control in women aged 18-45 years diagnosed with migraine who attend the Neurology Outpatient Clinic of Karabük University Karabük Training and Research Hospital. Participants who meet the inclusion and exclusion criteria will be randomly allocated into either a foot massage group or a control group using a simple randomization method. The foot massage group will receive a total of 10 sessions of foot massage over 5 weeks, with two sessions per week, while no massage intervention will be applied to the control group. All participants will be assessed at baseline, immediately after the intervention period, and two weeks following the completion of treatment. The findings of this study are expected to provide evidence regarding the effectiveness of foot massage in the management of symptoms in women with migraine.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Migraine is a primary headache type that usually manifests itself with unilateral, moderate to severe throbbing headaches, often accompanied by symptoms such as nausea, vomiting, and sensitivity to light and sound. The prevalence and impact of headaches are more pronounced, especially among women, and this condition is among the top five causes of disability in women. Reflexology, one of the complementary treatment methods, is an alternative medical practice that produces beneficial effects on the human body by applying pressure to specific points or areas called "reflex areas" on the feet, hands, and ears. Reflexology can be used as a complementary or supportive method of treatment because it is a massage form that regulates complex body functions and has relaxing and loosening effects. In studies; It has been found that foot reflexology reduces patients' pain and improves their sleep quality. The aim of this randomized controlled trial was to evaluate the effects of foot reflexology massage on pain, sleep, and quality of life in women with migraine. All patients included in this study will be evaluated with the following tests and scales three times: before, after, and 2 weeks after the end of the 5-week (10 sessions in total) treatment. After the initial evaluations of the study, migraine patients will be divided into 3 groups using a simple random sampling method in the computer randomization program. The first group will receive a foot reflexology massage. The second group will be the control group. The third group will be the sham group.

Tipo de estudio

Intervencionista

Inscripción (Actual)

36

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Turquía (Türkiye)
    • Karabük Province
      • Karabük, Karabük Province, Turquía (Türkiye), 78050
        • Karabuk University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Being a woman between the ages of 18 and 47
  • Having been diagnosed with migraine by a neurologist according to the International Headache Society (IHS) criteria
  • Volunteering to participate in the study
  • Being literate
  • Not having entered menopause

Exclusion Criteria:

  • Having any neurological disease other than migraine
  • Having a psychiatric illness
  • Smoking
  • Having a musculoskeletal disease affecting the head and neck area
  • Having a history of cervical or cranial surgery
  • Having irritation or ulceration in the skin area to be massaged
  • Receiving migraine treatment other than pharmacological treatment (acupuncture, dry needling, cupping, etc.)
  • Having diabetic foot
  • Having open wounds on the foot
  • Pregnant individuals or individuals who become pregnant during the study period

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: control group
The control group will not receive any foot reflexology therapy or other treatment intervention.
Experimental: Migraine group
Before starting foot reflexology treatment, patients will be informed about the treatment process. The treatment will be performed by a physiotherapist twice a week, with each session lasting 30 minutes, for a total of 10 sessions.
Procedimiento: foot reflexology

Before the treatment program begins, participants will be informed about the treatment procedure. The intervention will be administered by a physiotherapist certified as a Reflexology Practitioner, who has received formal training in reflexology. The treatment will consist of 10 sessions delivered over 5 weeks, with two 30-minute sessions per week.

Each session will begin with several passive ankle movements to promote relaxation of the foot and ankle region. Reflexology treatment will be applied first to the right foot and then to the left foot.

Target areas on the right foot: Brain, pineal gland, pituitary gland, hypothalamus and thalamus, temples, eye region and optic nerve, ear region, middle ear and balance point, and neck.

Additional areas treated on the right foot: Thyroid and parathyroid glands, lungs, liver, facial region, speech center, thymus gland, teeth, diaphragm, vertebral column, and extremities.

Areas treated on the left foot: Kidneys, diaphragm, intestines, n
Comparador falso: Sham group
superficial massage group
Otro: Sham massage
The sham group received a superficial massage on the soles of the feet, avoiding targeting reflexology points.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Headache Impact Test (HIT-6)
Periodo de tiempo: 2 days
The Headache Impact Test (HIT-6) is a self-report questionnaire designed to assess the impact of headache on quality of life. In 2021, Dikmen et al. conducted a study on the reliability and validity of the Turkish version of the Headache Impact Test (HIT-6) in migraine patients. The test items assess areas such as vitality, pain, and psychological distress, as well as sociability, role, and cognitive functioning. Three of the six items specifically address the previous four weeks, while the remaining three items do not have a defined time frame. Each item is answered using a 5-point Likert scale (6=never, 8=rarely, 10=sometimes, 11=very often, 13=always). The final score is calculated by summing the scores from all six items, ranging from 36 to 78 points. Impact is categorized on a scale of ≤49 points (very little or no impact), 50-55 points (some impact), 56-59 points (significant impact), and ≥60 points (strong impact), with higher scores indicating a greater impact.
2 days
Migraine Disability Assessment Scale
Periodo de tiempo: 2 days
The Migraine Disability Assessment Scale was used to measure the impact of migraine on a patient's life. This scale, consisting of 5 questions and 4 disability levels from I to IV (no or little disability, moderate, severe disability), was completed by patients during assessments one week before the injection, and during assessments 4 weeks (+7 days) and 12 weeks (+7 days) after the injection. Patients were asked questions about their work/school activities. The total score ranged from 0 to 27. Scores of 0-5 were classified as Level I, 6-10 as Level II, 11-20 as Level III, and scores above 21 as Level IV.
2 days
International Physical Activity Questionnaire-Short Form
Periodo de tiempo: 2 days
The International Physical Activity Questionnaire - Short Form is a reliable and valid self-report questionnaire developed to assess individuals' levels of physical activity. Recommended by the World Health Organization, this tool is widely used, particularly in epidemiological studies. The seven-question questionnaire provides information on time spent walking, moderate-to-vigorous, and vigorous activities. Time spent sitting is assessed as a separate question. Scoring involves summing the duration (minutes) and frequency (days) of walking, moderate-to-vigorous activity, and vigorous activity. A score of "MET-minutes" is obtained from these calculations. One MET-minute is calculated by multiplying the number of minutes spent on the activity by the MET score.
2 days
Beck Anxiety Scale
Periodo de tiempo: 2 days
The Beck Anxiety Scale (BAS) was developed to measure characteristic anxiety and worry symptoms in patients. This 21-item scale, with scores ranging from 0 to 63 (higher scores indicating severe anxiety), was completed by patients during assessments one week before the injection, and again four weeks (+7 days) and twelve weeks (+7 days) after the injection. The control group completed the scale once. For each item, patients selected one of the following options: 0 = none, 1 = mild, 2 = moderate, and 3 = severe, resulting in a total score ranging from 0 to 63. Scores of 0-7 were considered normal, 8-15 mild, 16-25 moderate, and 26-63 severe.
2 days
Assessment of postural control
Periodo de tiempo: 2 days
Postural balance will be assessed using a device that measures body sway by sensing foot pressure. The platform on the device detects body sways. The platform consists of a hard surface, but a soft surface can be achieved by placing a foam cushion on it. The platform must be placed on a flat surface so that it does not move. Through the platform, the individual's center of pressure is visualized, and oscillations occurring in the anteroposterior (AP) and mediolateral (ML) directions can be monitored. Changes occurring on the platform are displayed on a computer screen using Bertec Workbook software.
2 days
Tampa Kinesiophobia Scale
Periodo de tiempo: 2 days
The Tampa Kinesiophobia Scale (TMS) is a self-report scale developed to assess individuals' levels of avoidance of movement due to fear of pain or re-injury. Kinesiophobia is a significant psychological factor, particularly prevalent in individuals with chronic pain, and can lead to functional limitations by restricting participation in physical activity. The TMS consists of 17 items and is scored using a 4-point Likert scale; higher scores indicate a high level of fear of movement. The Turkish validity and reliability study was conducted by Yılmaz et al., and the scale is widely used in clinical and research settings.
2 days

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Karabuk University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de junio de 2026

Finalización primaria (Actual)

31 de agosto de 2026

Finalización del estudio (Actual)

31 de agosto de 2026

Fechas de registro del estudio

Enviado por primera vez

10 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de junio de 2026

Publicado por primera vez (Actual)

16 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de septiembre de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • KBU-FTR-NC-10

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Data are available from the corresponding author on reasonable request.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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