MigraineNCT07651839
The Effect of Foot Reflexology in Women With Migraine
A study testing foot reflexology in people with Migraine and Reflexology, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Migraine, Reflexology, Pain
- What is being tested?
- foot reflexology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 47 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabuk University
Karabük, Karabük Province, 78050
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Migraine, Reflexology, Pain, Anxiety, Kinesiophobia, Postural Control
- Being tested
- foot reflexology, Sham massage
- Medical subject headings
- Migraine Disorders, Pain, Anxiety Disorders, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot reflexologyProcedure or surgery
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
Sham massageOther
The sham group received a superficial massage on the soles of the feet, avoiding targeting reflexology points.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | The control group will not receive any foot reflexology therapy or other treatment intervention. |
| Migraine group | Experimental | 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. Receives: Procedure: foot reflexology |
| Sham group | Sham comparator | superficial massage group Receives: Other: Sham massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Impact Test (HIT-6)
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.
Measured: 2 days
Migraine Disability Assessment Scale
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.
Measured: 2 days
International Physical Activity Questionnaire-Short Form
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.
Measured: 2 days
Beck Anxiety Scale
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.
Measured: 2 days
Assessment of postural control
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.
Measured: 2 days
Tampa Kinesiophobia Scale
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start15 Jun 2026
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurcan Contarli, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651839
- Sponsor's protocol ID
- KBU-FTR-NC-10
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Reflexology on Pain, Disability, Anxiety, Kinesiophobia, and Postural Control in Women With Migraine
- ClinicalTrials.gov ID
- NCT07651839
- Acronym / sponsor ID
- KBU-FTR-NC-10
- Conditions
- Migraine, Reflexology, Pain, Anxiety, Kinesiophobia, Postural Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –The control group will not receive any foot reflexology therapy or other treatment intervention. |
| Migraine group | Experimental | Procedure: foot reflexologyBefore 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. |
| Sham group | Sham comparator | Other: Sham massagesuperficial massage group |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| foot reflexologyBefore 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 | Procedure or surgery | Migraine group |
| Sham massageThe sham group received a superficial massage on the soles of the feet, avoiding targeting reflexology points. | Other | Sham group |
Primary outcome
Headache Impact Test (HIT-6)
Time frame: 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.
Migraine Disability Assessment Scale
Time frame: 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.
International Physical Activity Questionnaire-Short Form
Time frame: 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.
Beck Anxiety Scale
Time frame: 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.
Assessment of postural control
Time frame: 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.
Tampa Kinesiophobia Scale
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No. Data are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing foot reflexology in people with Migraine and Reflexology, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Impact Test (HIT-6) (time frame: 2 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.