Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-01-02 @ 1:15 PM
Study NCT ID:
NCT07125820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dual Intervention in Migraine Treatment: Tens and Exercise
Sponsor:
Suleyman Demirel University
Organization:
Study Overview
Official Title:
Effects of Transcutaneous Electrical Nerve stimulatıon and Exercise Training on Pain and functionalıty in Women With Migraine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: