Investigation of the Effect of Cold Application in Migraine

NCT05454826 | Completed

• 1 other identifier: migraine
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Cold; Relaxation; Exercise

Outcome Measures

Primary Outcomes (1)

• Migraine Disability Assessment questionnaire

  The Migraine Disability Assessment questionnaire (MIDAS) questionnaire was developed to measure the effect of headaches on a person's daily functioning. MIDAS takes into account the last three months and consists of five questions. It is a simple and short survey. These questions are used to determine your score and are then matched to a disability level. As the score increases, the severity of migraine pain increases.

  0-6. week

Secondary Outcomes (3)

• World Health Organization quality of life scale ('whoqol-bref')

  0-6. week

• Visual Analog Scale

  0-6. week

• Patient case form

  0-6. week

Study Arms (2)

Cold application group

EXPERIMENTAL

applied relaxation exercise+ cold pack

Other: Cold Application

control group

EXPERIMENTAL

applied relaxation exercise

Other: Exercise

Interventions

Exercise OTHER

1st group (n=15) relaxation exercises, 2nd group (n=15) relaxation exercises+cold compression. The exercise program will be applied for 6 weeks, 3 days a week \* 45 minutes. Relaxation exercises will be applied to the patients 3 days a week using web-based methods (Zoom).

Also known as: Relaxation exercise applications

control group

Cold Application OTHER

1st group (n=15) relaxation exercises, 2nd group (n=15) relaxation exercises+cold compression. The exercise program will be applied for 6 weeks, 3 days a week \* 45 minutes. Relaxation exercises will be applied to the patients 3 days a week using web-based methods (Zoom).

Also known as: Relaxation exercise+ cold pack applications

Cold application group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eylül Pınar KISA: lead

Study Sites (1)

Eylül Pınar Kısa

Istanbul, Istanbul, 34720, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders; Common Cold; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: August 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: May 30, 2023
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

TU (1)