Therapeutic Ultrasound in the Treatment of Migraine
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|ClinicalTrials.gov Identifier: NCT03459495|
Recruitment Status : Not yet recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Migraine Ultrasound||Device: therapeutic ultrasound Device: placebo ultrasound||Not Applicable|
Evidence from controlled studies suggests that non-invasive physical therapies may help prevent headaches. Therapeutic ultrasound studies have generally been used in combination with other physical therapies.
Therapeutic ultrasound is known to act in two different ways, thermal and non-thermal. With thermal effect, it is possible to reduce pain and joint joints and increase local blood flow, while stimulating tissue regeneration, soft tissue repair, blood flow regulation in chronic ischemic tissues and protein synthesis with nonthermal effect. In addition, its effect on inflammation accelerated repair by affecting cell activities, altering platelet membrane permeability, leading to the release of serotonin and accelerating wound healing.
The aim of this study is to determine whether therapeutic ultrasound is superior to placebo ultrasound in the treatment of migraine.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||prospective,randomized,placebo- controlled, double blind|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Investigation of the Efficacy of Therapeutic Ultrasound in the Treatment of Migraine; Prospective, Randomized, Placebo Controlled, Double-blind Study|
|Estimated Study Start Date :||March 10, 2018|
|Estimated Primary Completion Date :||September 10, 2018|
|Estimated Study Completion Date :||September 10, 2018|
Active Comparator: Group A
Group A: ultrasound group
Device: therapeutic ultrasound
Patients in the ultrasound group will be administered to the posterior neck region for 5 minutes in pulsed mode (pulse rate 1: 1) at 1 MHz, 1.5 W / cm2. The treatment will be done 5 days a week for a total of 10 days
Placebo Comparator: Group P
Group P: placebo ultrasound group
Device: placebo ultrasound
When the ultrasonic device is in the closed position, the ultrasonic probe will be applied for 5 minutes in the posterior neck region of the patients. The treatment will be done 5 days a week for a total of 10 days.
- Numeric rating scale (NRS) [ Time Frame: 4 months ]It is commonly used to measure the severity of the patients' pain. It consists of a line 10 cm. long and marked with numbers from 0 to 10. The patient is asked to mark the point corresponding to the severity of the pain on this line in the range from 0 (no pain) to 10 (most severe pain).
- Migraine Disability Assessment Questionnaire Score (MIDAS) [ Time Frame: 4 months ]
The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self-administered questionnaire designed to quantify headache-related disability over a 3 month period. The MIDAS score is based on five disability questions in three dimensions: questions one and two assess the number of missed or significant limitations to activity (defined as at least 50% reduced productivity) days due to headache in school or paid work activities (school/job dimension); questions three and four assess the number of missed or significant limitations to activity (defined as at least 50% reduced productivity) days due to headache in housework activities (housework dimension); question five assesses missed days due to headache in family, social, or leisure activities (social dimension).
0 to 5 - MIDAS Grade I, Little or no disability 6 to 10 - MIDAS Grade II, Mild disability 11 to 20 - MIDAS Grade III, Moderate disability 21+ - MIDAS Grade IV, Severe disability
- paracetamol consumption [ Time Frame: 4 months ]
- the number of migraine attacks per month. [ Time Frame: 4 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459495
|Contact: Burcu Metin Ökmen, M.D.||+firstname.lastname@example.org|
|Principal Investigator:||Burcu Metin Ökmen||University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital|