CClinicalTrials.gg
CompletedNCT06828315migraineUpdated Mar 4, 2026Results posted

the Effect of Reflexology in Migraine Patients

An interventional study of Reflexology in Reflexology, Migraine and Pain, sponsored by Muş Alparslan University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-04.

Sponsored by Muş Alparslan University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Oct 2024, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Reflexology
  • Migraine
  • Pain
  • Fatigue
  • Quality of Life
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 78 is close to the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Muş Alparslan University is the lead sponsor of 60 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    experimental group

    reflexology was applied to the experimental group

    Other: Reflexology

  • No intervention
    control group

    reflexology was not applied to the control group

Interventions

  • OtherReflexology

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the end of the 5-week intervention

  2. 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.

    Time frame: At the end of the 5-week intervention

  3. 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.

    Time frame: At the end of the 5-week intervention

07

Results

Posted Mar 4, 2026
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.

Participant flow

Pre-Intervention (Baseline)
Participant flow — Pre-Intervention (Baseline)
MilestoneExperimental GroupControl Group
Started3939
Completed3939
Not completed00
Post-Intervention (At the End of Week 5)
Participant flow — Post-Intervention (At the End of Week 5)
MilestoneExperimental GroupControl Group
Started3939
Completed3939
Not completed00

Outcome measures

PrimaryVisual 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.

Time frame:
At the end of the 5-week intervention
Reported as:
Mean · Score (0-10)
Visual Analog Scale (VAS)
Score (0-10)Experimental GroupControl Group
Visual Analog Scale (VAS)4.15 ± 1.637.46 ± 1.48
PrimaryFatigue 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.

Time frame:
At the end of the 5-week intervention
Reported as:
Mean · Score (9-63)
Fatigue Severity Scale (FSS)
Score (9-63)Experimental GroupControl Group
Fatigue Severity Scale (FSS)32.97 ± 6.7442.28 ± 6.39
Primary24-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.

Time frame:
At the end of the 5-week intervention
Reported as:
Mean · Score (15-105)
24-Hour Migraine-Specific Quality of Life Questionnaire (24 h MQoLQ)
Score (15-105)Experimental GroupControl Group
24-Hour Migraine-Specific Quality of Life Questionnaire (24 h MQoLQ)81.05 ± 8.9769.51 ± 8.99

Adverse events

Collected over 5 week. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Experimental Group0/39 (0%)0/39 (0%)0/39 (0%)
Control Group0/39 (0%)0/39 (0%)0/39 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Year)Experimental GroupControl GroupTotal
Mean42.76 ± 12.2338.41 ± 10.6340.58 ± 11.59
Sex: Female, Male
Sex: Female, Male(Participants)Experimental GroupControl GroupTotal
Female252449
Male141529
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Experimental GroupControl GroupTotal
Count of participants——0
Baseline Pain Intensity (Visual Analog Scale)
Baseline Pain Intensity (Visual Analog Scale)(Score (range 0-10))Experimental GroupControl GroupTotal
Mean7.26 ± 1.487.59 ± 1.257.42 ± 1.37
Baseline Fatigue Severity
Baseline Fatigue Severity(Score (9-63))Experimental GroupControl GroupTotal
Mean43.77 ± 5.1143.10 ± 5.7343.43 ± 5.41
Baseline Migraine-Specific Quality of Life
Baseline Migraine-Specific Quality of Life(Score (15-105))Experimental GroupControl GroupTotal
Mean68.15 ± 8.2767.59 ± 6.0167.87 ± 7.18
08

Study locations

1 site
  • Muş Alparslan University
    Muş, Turkey (Türkiye)
09

References and documents

Study documents

  • Protocol, analysis plan and consent form · Feb 23, 2025

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06828315
Lead sponsor
Muş Alparslan University
Responsible party
Cihat Demirel (Assistant Professor, Muş Alparslan University) — Principal investigator
First posted
Feb 14, 2025
Start date
Oct 10, 2024
Primary completion
Nov 15, 2024
Completion
Feb 10, 2025
Results posted
Mar 4, 2026
Last update
Mar 4, 2026

Study contacts

Cihat Demirel
principal investigator · Muş Alparslan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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