NCT07028684

Brief Summary

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.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 2 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

June 11, 2025

Last Update Submit

April 14, 2026

Conditions

Keywords

MigraineMassageHeadache

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    Pain intensity will be assessed with a visual analog scale. The patient marks his/her own pain on a 10 (represents "worst pain imaginable") cm ruler with painlessness 0 (represents "no pain") at one end and the most severe pain possible at the other end.

    5 weeks

Secondary Outcomes (4)

  • Headache Impact Test

    Five weeks

  • Pittsburgh Sleep Quality Index

    Five weeks

  • Migraine disability assessment

    Five weeks

  • 24-h Migraine Quality of Life Questionnaire

    Five weeks

Study Arms (2)

Control

NO INTERVENTION

No treatment other than medication will be given for migraine.

Experimental

EXPERIMENTAL

Reflexology massage will be applied twice a week for 30 minutes per session, for a total of 10 sessions.

Other: Reflexology Massage

Interventions

Reflexology massage will be applied twice a week for 30 minutes per session, for a total of 10 sessions. The treatment will begin by relaxing the ankle with a few passive movements. Reflexology massage will be applied to the right foot first and then to the left foot. Target Areas to be Applied to the Right Foot: Brain, Pineal, Hypophysis, Hypothalamus and Thalamus, Temples, Eye area and Optic nerve, Ear area, Middle ear and Balance point, Neck. Other areas to be applied to the right foot: Thyroid and Parathyroid, Lung, Liver, Face area, Speech center and Thymus, Teeth, Diaphragm, Vertebra, Extremities. Areas to be applied to the left foot: Kidney, Diaphragm, Intestines, Neck, Vertebra, Extremities. The session is completed from the left foot by applying to the lymph inlet, lymph channel and diaphragm from both feet.

Experimental

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 18-45
  • Being diagnosed with migraine by a neurologist according to the International Headache Society (IHS) criteria
  • Volunteering to participate in the study
  • Being able to read and write
  • Not having entered menopause

You may not qualify if:

  • Any neurological or musculoskeletal disease other than migraine
  • History of cervical or cranial surgery
  • Irritation or ulceration on the skin area to be reflexologized
  • Receiving non-drug migraine treatment (acupuncture, dry needle, etc.)
  • Those who have received physiotherapy at least 6 months ago
  • Presence of diabetic foot
  • Open wounds on the foot
  • Pregnant individuals or individuals who become pregnant during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine DisordersHeadache

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study includes two groups with massage and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 19, 2025

Study Start

June 1, 2025

Primary Completion

December 15, 2025

Study Completion

March 15, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations