Effects of Transcutaneous Electrical Nerve stimulatıon and Exercise Training on Pain and functionalıty in Women With Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Assessment of Pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
A single-blind study was designed in which the patients would be unaware of their group allocation
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Experimental Group (Other)
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
干预措施: control group (Other)
结局指标
主要结局
Assessment of Pain
时间窗: eight weeks and 4th week control after treatment
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
Assessment of Disability
时间窗: eight weeks
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).
次要结局
- Evaluation of Muscle Performance(8 weeks)
- Assessment of Sleep Quality(eight weeks)
- Assessing Balance(eight weeks)
- Assessing Flexibility(eight weeks)
- Assessment of Quality of Life(eight weeks)
研究者
Nur ALP
Lecturer, MSc.
Suleyman Demirel University