Clinical trial NCT05454826: Investigation of the Effect of Cold Application in Migraine
Official title: Investigation of the Effect of Cold Application in Addition to Relaxation Exercises in Patients with Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Cold
Relaxation
Exercise
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Migraine is a headache that is paroxysmal and can last for hours, sometimes even days due to untreated or ineffective treatment is usually unilateral, throbbing, severe enough to prevent the person's daily life activities, and increases with head movements. It is a chronic disorder characterized by recurrent moderate and severe headaches, mostly associated with a few symptoms in the autonomic nervous system. Migraine consists of recurrent headache attacks accompanied by neurological, gastrointestinal, and autonomic symptoms.

Migraine is the most common chronic headache in epidemiological studies. Studies have shown that migraine affects 12% of the general population. The aim of migraine treatment is to reduce the frequency, duration, and severity of migraine attacks, to reduce the losses caused by migraine, and increase the quality of life.

In the treatment of migraine, non-pharmacological treatment is as important as pharmacological treatment. Some individuals prefer drug-free treatment methods because of the side effects drugs. In recent years, as the mechanisms of headaches have been better understood, significant developments have been made in treatment methods. Different physiotherapy and rehabilitation methods have been used for treatment. There are studies in which cold application is used in migraine patients, but a study evaluating the effectiveness of cold application has not been found in the literature. The systemic effects of cold have two main purposes: to maintain the current body temperature and to produce energy to raise the fallen body temperature. Knowing both the local and systemic effects of cold guides its use in treatment. The aim of this study was to diagnose migraine.

To investigate the effectiveness of cold application applied in addition to relaxation exercises in individuals.

Detailed description: Thirty migraine patients diagnosed by a physician will be included in our study.

Participants will be divided into two groups as randomized controlled. Only relaxation exercises will be applied to a group for 6 weeks, 3 days a week. In the other group, relaxation In addition to the exercises, cold will be applied. The sociodemographic information of the patients will be evaluated with the "patient case form", the pain severity will be evaluated with the "visual analog scale" and the quality of life will be evaluated with the world health organization quality of life scale ('whoqol-bref').

Migraine disability rating scale (MIDAS) will be used for functionality. Statistical analysis of data SPSS It will be done using the 24.0 (Statistical Package for Social Sciences) program and p≤0.05 will be considered statistically significant in all analyzes.

The reason why the investigators chose cold application in addition to relaxation exercises in our study is that it is a low-cost, risk-free method that everyone can access. It is also an easy-to-apply method.

Eligibility criteria: Inclusion Criteria:

* be between 20-45 years old
* Having been diagnosed with migraine at least 6 months ago
* Patient's ability to use a computer

Exclusion Criteria:

* Being in the period of menstruation
* Sensitivity to cold (those who have 5 or more sensitivity on a 10 cm scale)
* Having any neurological or orthopedical problems
* Using antidepressants etc.
* Poor mental state

Primary outcomes:
measure: Migraine Disability Assessment questionnaire
timeFrame: 0-6. week
Secondary outcomes:
measure: World Health Organization quality of life scale ('whoqol-bref')
timeFrame: 0-6. week
measure: Visual Analog Scale
timeFrame: 0-6. week
measure: Patient case form
timeFrame: 0-6. week
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Eylül Pınar Kısa
state: İstanbul
Study officials:
References: