A Dual Intervention in Migraine Treatment: Tens and Exercise

Suleyman Demirel University

Status: Not yet enrolling

Conditions: Migraine

Treatments: Other: control group; Other: Experimental Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07125820

BaskentU-FTR-KA25/136

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Patient education, TENS application and Exercise program

Experimental group

Description:

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.

Treatment:

Other: Experimental Group

Placebo TENS Application,Home Exercise Program and patient education program

Active Comparator group

Description:

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

Treatment:

Other: control group