A Dual Intervention in Migraine Treatment: Tens and Exercise

NCT07125820 | Not Yet Recruiting

• 1 other identifier: BaskentU-FTR-KA25/136
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

Migraine; Tens; Exercise

Outcome Measures

Primary Outcomes (2)

• Assessment of Pain

  Pain intensity, frequency, duration and medication use of the individuals will be evaluated every week with a pain diary. Numeric Pain Scale will be used to assess pain intensity. Individuals will be asked to mark their pain intens

  eight weeks and 4th week control after treatment

• Assessment of Disability

  Migraine Disability Assessment Questionnaire (MIDAS) was developed by Stewart et al. (56) in 1999 to measure migraine-related disability. The Turkish validity and reliability of the scale was studied by Ertaş et al. in 2004 (57). Gedikoğlu et al. (58) demonstrated the validity and reliability of the scale in migraine patients in 2005. The questions in the scale provide the determination of the number of days they cannot participate in school/work, home and leisure time activities due to migraine pain. A total score is obtained with the average score of these five questions. Scoring is divided into 4 groups; Group 1: Little or no impairment (0-5 days missing) Group 2: Mild impairment (6-10 days missing) Group 3: Moderate impairment (11-20 days missing) Group 4: Severe impairment (21 days or more).

  eight weeks

Secondary Outcomes (5)

• Evaluation of Muscle Performance

  8 weeks

• Assessing Flexibility

  eight weeks

• Assessment of Sleep Quality

  eight weeks

• Assessing Balance

  eight weeks

• Assessment of Quality of Life

  eight weeks

Study Arms (2)

Patient education, TENS application and Exercise program

EXPERIMENTAL

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.

Other: Experimental Group

Placebo TENS Application,Home Exercise Program and patient education program

ACTIVE COMPARATOR

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

Other: control group

Interventions

Experimental Group 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.

Patient education, TENS application and Exercise program

control group 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.

Placebo TENS Application,Home Exercise Program and patient education program

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Baskent University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• VEDAT ALİ YÜREKLİ, Neurology Professor

  Suleyman Demirel University

  STUDY DIRECTOR

Central Study Contacts

NUR ALP, MSc

CONTACT

+905339738832; nuralp@sdu.edu.tr

OZLEM YURUK, Professor

CONTACT

+05323272755; bastug@baskent.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A single-blind study was designed in which the patients would be unaware of their group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, MSc.

Model Details: The study is planned as a randomized controlled prospective clinical trial. 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

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 15, 2025
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 5, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)