A Dual Intervention in Migraine Treatment: Tens and Exercise

NCT07125820 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-05-07

No results posted yet for this study

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

Interventions

OTHER

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.

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.

Sponsors & Collaborators

  • Suleyman Demirel University

    lead OTHER

Principal Investigators

  • VEDAT ALİ YÜREKLİ, Neurology Professor · Suleyman Demirel University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-05-01
Completion
2026-05-15

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07125820 on ClinicalTrials.gov