A Dual Intervention in Migraine Treatment: Tens and Exercise

NCT ID: NCT07125820

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2025-12-05

Brief Summary

The aim of this clinical trial was to investigate the effects of TENS and exercise training on pain and disability in women diagnosed with migraine. The second aim was to investigate the effects of TENS and exercise training on muscle strength, flexibility, sleep quality, balance, and quality of life in women diagnosed with migraine.

Study hypotheses:

H1: TENS and exercise training are effective on pain in women with migraine. H2: TENS and exercise training are effective on disability in women with migraine.

H3: TENS and exercise training are effective on muscle performance in women with migraine.

H4: TENS and exercise training are effective on flexibility in women with migraine.

H5: TENS and exercise training are effective on sleep quality in women with migraine.

H6: TENS and exercise training are effective on balance in women with migraine. H7: TENS and exercise training are effective on quality of life in women with migraine.

Detailed Description

The study will be conducted on volunteer patients diagnosed with migraine by a specialist physician in the Department of Neurology of Isparta Süleyman Demirel University Hospital. All stages of the study will be conducted at Isparta Süleyman Demirel University. Informed consent form will be obtained from all patients participating in the study.

There are two groups in the study: Study and control group. Individuals in both groups will continue the medication recommended by the physician for migraine attacks. In addition, after the initial evaluation, individuals in both groups will be given a session of patient education consisting of lifestyle recommendations for triggering factors in migraine by a specialist physiotherapist, which will last approximately 30 minutes. After this session, patients will be given a brochure prepared by the researchers. The brochure will include recommendations on nutrition, environment, sleep, physical activity and stress Participants.Study Group In addition to drug treatment and patient education, TENS application and exercise program will be given to the individuals in the study group.Patients will be treated at Isparta Süleyman Demirel University Department of Neurology. The treatment program will last 3 days a week for a total of 8 weeks.

Control Group Individuals in the control group will receive a single session of placebo TENS application and home exercise program in addition to drug treatment and patient education.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Patient education, TENS application and Exercise program

Study Group In addition to drug treatment and patient education, TENS application and exercise program will be given to the individuals in the study group.Patients will be treated at Isparta Süleyman Demirel University Department of Neurology. The treatment program will last 3 days a week for a total of 8 weeks.In this group, TENS application will be performed 3 days a week, 1 session a day for 8 weeks. Cefar brand digital device of Chattanoga company TENS will be used in the application. The frequency will be set as 100 Hz and the transition time as 100 µsec. The application will be performed for 20 minutes.Patients in this group will be given an exercise program 3 days a week for 8 weeks under the supervision of a physiotherapist. The program will include cervical stabilization exercises, stretching and balance exercises. The program is planned in accordance with the principle of progression from easy to difficult every two weeks and is given in.

Group Type: EXPERIMENTAL

Experimental Group

Intervention Type: OTHER

There are two groups: a study group and a control group. Both groups will continue taking their doctor-prescribed medications for migraine attacks. After the initial assessment, both groups will receive a 30-minute education and brochure containing lifestyle recommendations to address migraine triggers. The brochure will include recommendations for nutrition, environment, sleep, physical activity, and stress. Additionally, a Chattanooga Cefar® TENS device will be used. The frequency will be set at 100 Hz and the transition time will be set at 100 µs. The session will last 20 minutes. Individuals in the study group will be assigned an exercise program. Patients in this group will exercise in-person three days a week for eight weeks under the supervision of a physical therapist. The program will include cervical stabilization exercises, stretching, and balance exercises. The program is planned with a progression from easy to more difficult every two weeks.

Placebo TENS Application,Home Exercise Program and patient education program

Control Group Individuals in the control group will receive a single session of placebo TENS application and home exercise program in addition to drug treatment and patient education.This program will only consist of stretching exercises for the trapezius and levator scapula muscles. The exercises will be recommended to be performed once a day, 3 days a week, for 8 weeks with 10 repetitions. The number, frequency and duration of the exercises will not be increased. The home program will not be followed up by the physiotherapist

Group Type: ACTIVE_COMPARATOR

control group

Intervention Type: OTHER

Individuals in the control group will receive a single session of placebo Chattanooga Cefar® TENS application and home exercise program in addition to drug treatment and patient education.Patients in this group will receive a single session of placebo TENS. Electrodes will be placed as in the study group. The physiotherapist will turn on the device but will not increase the current. Thus, the stimulation light of the device will be on but no current will be delivered. Patients will be told that they will not feel anything during the treatment and that this is a feature of the application. The application will be performed for 20 minutes.Home Exercise Program After the initial evaluation and patient education, patients will be offered an exercise program to be performed at home. This program will only consist of stretching exercises for the trapezius and levator scapula muscles. The exercises will be recommended to be performed once a day, 3 days a week, for 8 weeks with 10 repetitions.

Interventions

Experimental Group

There are two groups: a study group and a control group. Both groups will continue taking their doctor-prescribed medications for migraine attacks. After the initial assessment, both groups will receive a 30-minute education and brochure containing lifestyle recommendations to address migraine triggers. The brochure will include recommendations for nutrition, environment, sleep, physical activity, and stress. Additionally, a Chattanooga Cefar® TENS device will be used. The frequency will be set at 100 Hz and the transition time will be set at 100 µs. The session will last 20 minutes. Individuals in the study group will be assigned an exercise program. Patients in this group will exercise in-person three days a week for eight weeks under the supervision of a physical therapist. The program will include cervical stabilization exercises, stretching, and balance exercises. The program is planned with a progression from easy to more difficult every two weeks.

Intervention Type: OTHER

control group

Individuals in the control group will receive a single session of placebo Chattanooga Cefar® TENS application and home exercise program in addition to drug treatment and patient education.Patients in this group will receive a single session of placebo TENS. Electrodes will be placed as in the study group. The physiotherapist will turn on the device but will not increase the current. Thus, the stimulation light of the device will be on but no current will be delivered. Patients will be told that they will not feel anything during the treatment and that this is a feature of the application. The application will be performed for 20 minutes.Home Exercise Program After the initial evaluation and patient education, patients will be offered an exercise program to be performed at home. This program will only consist of stretching exercises for the trapezius and levator scapula muscles. The exercises will be recommended to be performed once a day, 3 days a week, for 8 weeks with 10 repetitions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Sedentary female individuals aged 18-55 years
• Being diagnosed with migraine according to the International Headache Society (IHS) criteria
• Having at least 2 migraine attacks per month
• Having started the use of medical medication for migraine treatment 3 months or earlier
• Not taking medication continuously except for migraine attacks

Exclusion Criteria

• Having vestibular migraine
• Having another type of concomitant headache
• Becoming pregnant
• Being breastfeeding
• History of trauma or surgery in the craniocervical region
• Presence of concomitant neurological (multiple sclerosis, Parkinson's disease, etc.) and/or inflammatory rheumatic diseases (ankylosing spondylitis, rheumatoid arthritis, etc.)
• Presence of psychiatric problems (schizophrenia, bipolar disorder, etc.)
• History of malignancy
• Physiotherapy and rehabilitation for migraine or cervical region in the last 6 months
• Botox / filler application to the face area
• Not attending research sessions regularly or missing 3 consecutive sessions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Suleyman Demirel University

OTHER

Sponsor Role: lead

Responsible Party

Nur ALP

Lecturer, MSc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

VEDAT ALİ YÜREKLİ, Neurology Professor

Role: STUDY_DIRECTOR

Suleyman Demirel University

Locations

Baskent University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

NUR ALP, MSc

Role: CONTACT

nuralp@sdu.edu.tr

+905339738832

OZLEM YURUK, Professor

Role: CONTACT

bastug@baskent.edu.tr

+05323272755

Other Identifiers

BaskentU-FTR-KA25/136

Identifier Type: -

Identifier Source: org_study_id