the Effect of Reflexology in Migraine Patients (migraine)

February 12, 2026 updated by: Cihat Demirel, Muş Alparslan University

Foot Reflexology as an Adjunctive Therapy in Migraine Management: A Randomized Controlled Trial on Pain, Fatigue, and Quality of Life

The aim of this randomised controlled trial was to evaluate the effect of foot reflexology on pain intensity, fatigue and quality of life in migraine patients.

The main questions it aims to answer are:

Is foot reflexology effective in reducing pain intensity in migraine patients? Is foot reflexology effective in reducing the fatigue level of migraine patients? Is foot reflexology effective in improving the quality of life of migraine patients? Comparison group: The researchers will evaluate the effects of foot reflexology by comparing the group receiving reflexology intervention with the control group receiving only routine treatment.

Participants were selected according to the following criteria:

Intervention group: Individuals diagnosed with migraine will receive foot reflexology twice a week for a total of 10 sessions.

Control group: No additional intervention will be applied to this group, only their routine treatment and medical follow-up will continue.

Both groups will be evaluated at the beginning and at the end of the study with the Patient Information Form, Migraine 24-Hour Quality of Life Scale (QoLQS), Visual Analogue Scale (VAS) and Fatigue Severity Scale (FSS). After the completion of the study, reflexology will be applied to patients in the control group who are willing to receive reflexology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Being between the ages of 18-60 (to conduct the study with adult individuals and to minimise the effect of age-related variables)
  2. Being diagnosed with migraine
  3. Having experienced at least 2 migraine attacks in the last 6 months (to ensure a homogenous group among patients with more chronic or episodic migraine)
  4. Migraine with a severity of 4 or more with VAS (Visual Analogue Scale) (To prevent mild headaches from affecting the study)
  5. Having experienced at least 2 migraine attacks in the last 6 months (to ensure a homogenous group among patients with more chronic or episodic migraine)
  6. To participate and continue to work as a volunteer

Exclusion Criteria:

  1. For female participants: Being pregnant or breastfeeding (as hormone changes may change the effect of migraine and reflexology)
  2. Having another chronic neurological disease (epilepsy, MS, Parkinson's, etc.) (to avoid the effect of symptoms that may be confused with migraine)
  3. Being treated with another alternative medicine method (acupuncture, biofeedback, etc.) at the same time (to measure the independent effect of reflexology)
  4. Regular use of Botox, nerve blockade or invasive treatment for migraine in the last 3 months (to reduce the influence of external factors on migraine severity)
  5. Severe psychiatric disorders (schizophrenia, bipolar disorder, etc.) or a history of severe depression/anxiety (to isolate the effect of stress and psychological factors on reflexology)
  6. No previous serious side effects or intolerance to reflexology (important for safety)
  7. Diabetic neuropathy, severe peripheral neuropathy or severe dermatological disorders (infection, open wound, etc.) in the foot area (as it may affect the applicability of reflexology)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
reflexology was applied to the experimental group
Other: Reflexology
Reflexology is a practice based on the fact that the organs in the body are connected to the reflex areas in the hands and feet.
No Intervention: control group
reflexology was not applied to the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: At the end of the 5-week intervention
Pain intensity was assessed using the Visual Analog Scale (VAS) for Pain. The Visual Analog Scale is a unidimensional measure of perceived pain intensity. It consists of a 10-centimeter horizontal line anchored by two descriptors: "no pain" (0) and "worst imaginable pain" (10). Participants mark a point on the line corresponding to their perceived pain intensity, resulting in a score ranging from 0 to 10. Higher scores indicate greater pain severity and represent a worse outcome. Lower scores indicate less pain and represent a better outcome.
At the end of the 5-week intervention
Fatigue Severity Scale (FSS)
Time Frame: At the end of the 5-week intervention
The Fatigue Severity Scale (FSS) will be used to evaluate changes in participants' fatigue levels. The FSS consists of nine items scored from 1 to 7, with higher scores indicating greater fatigue severity. The total score ranges from a minimum of 9 to a maximum of 63.
At the end of the 5-week intervention
24-Hour Migraine-Specific Quality of Life Questionnaire (24 h MQoLQ)
Time Frame: At the end of the 5-week intervention
24-Hour Migraine-Specific Quality of Life Questionnaire (24 h MQoLQ) will assess changes in migraine-specific quality of life. It includes five subscales: Migraine Symptoms, Emotions and Concerns, Work Functionality, Social Functionality, and Energy/Vitality. Higher scores indicate better quality of life. The total score ranges from a minimum of 15 to a maximum of 105.
At the end of the 5-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muş Alparslan University

Investigators

  • Principal Investigator: Cihat Demirel, Muş Alparslan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2024

Primary Completion (Actual)

November 15, 2024

Study Completion (Actual)

February 10, 2025

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • migraine

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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