the Effect of Reflexology in Migraine Patients

NCT06828315 | Completed Results

• 1 other identifier: migraine
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Quality of Life; Reflexology; Migraine; Pain; Fatigue

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale (VAS)

  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)

  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)

  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

Study Arms (2)

experimental group

EXPERIMENTAL

reflexology was applied to the experimental group

Other: Reflexology

control group

NO INTERVENTION

reflexology was not applied to the control group

Interventions

Reflexology OTHER

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.

experimental group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being between the ages of 18-60 (to conduct the study with adult individuals and to minimise the effect of age-related variables)
• Being diagnosed with migraine
• 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)
• Migraine with a severity of 4 or more with VAS (Visual Analogue Scale) (To prevent mild headaches from affecting the study)
• 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)
• To participate and continue to work as a volunteer

You may not qualify if:

• For female participants: Being pregnant or breastfeeding (as hormone changes may change the effect of migraine and reflexology)
• Having another chronic neurological disease (epilepsy, MS, Parkinson's, etc.) (to avoid the effect of symptoms that may be confused with migraine)
• Being treated with another alternative medicine method (acupuncture, biofeedback, etc.) at the same time (to measure the independent effect of reflexology)
• 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)
• 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)
• No previous serious side effects or intolerance to reflexology (important for safety)
• 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)

Sponsors & Collaborators

• Muş Alparslan University: lead

Study Sites (1)

Muş Alparslan University

Muş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders; Pain; Fatigue

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Limitations and Caveats

Single-center design may limit generalizability. The absence of a placebo (sham reflexology) control group may not fully account for expectancy or nonspecific effects. Blinding was limited to outcome assessment. Additionally, no long-term follow-up was conducted to evaluate the durability of the intervention effects.

Results Point of Contact

• Title: Assistant Professor Cihat DEMİREL
• Organization: Muş Alparslan University

cihatdemirel34@gmail.com

+90 5536186477

Study Officials

• Cihat Demirel

  Muş Alparslan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 14, 2025
• Study Start: October 10, 2024
• Primary Completion: November 15, 2024
• Study Completion: February 10, 2025
• Last Updated: March 4, 2026
• Results First Posted: March 4, 2026

Record last verified: 2026-02

Locations

TU (1)