Clinical trial NCT06828315: the Effect of Reflexology in Migraine Patients
Official title: Foot Reflexology as an Adjunctive Therapy in Migraine Management: A Randomized Controlled Trial on Pain, Fatigue, and Quality of Life
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Reflexology
Migraine
Pain
Fatigue
Quality of Life
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: At the end of the 5-week intervention
measure: Fatigue Severity Scale (FSS)
timeFrame: At the end of the 5-week intervention
measure: 24-Hour Migraine-Specific Quality of Life Questionnaire (24 h MQoLQ)
timeFrame: At the end of the 5-week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Muş
country: Turkey
facility: Muş Alparslan University
Study officials:
affiliation: Muş Alparslan University
name: Cihat Demirel
role: PRINCIPAL_INVESTIGATOR
References: