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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
Sponsor:
Information provided by (Responsible Party):
Dr. Burcu Metin Ökmen, Bursa Yüksek İhtisas Education and Research Hospital

Brief Summary:
Headache affects the daily quality of life of patients. It has been reported that headaches may be associated with neck muscles, neck movements and trigger points in the neck Drug and non-drug treatments can be used today in the treatment of headaches. Various physical therapies are applied to cranial and cervical regions in non-drug therapies. Therapeutic ultrasound, Transcutaneous Electrical Nerve Stimulation (TENS), Hotpack and manipulation are some of them.This is a randomised placebo- controlled trial to determine the efficacy of the therapeutic ultrasound in the treatment of migraine.

Condition or disease Intervention/treatment Phase
Migraine Ultrasound Device: therapeutic ultrasound Device: placebo ultrasound Not Applicable

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective,randomized,placebo- controlled, double blind
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine Ultrasound

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).

  2. 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



Secondary Outcome Measures :
  1. paracetamol consumption [ Time Frame: 4 months ]
  2. the number of migraine attacks per month. [ Time Frame: 4 months ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between 20-65 years
  • Patients diagnosed with migraine according to the International Headache Society (IHS) criteria

Exclusion Criteria:

  • Patients with bleeding disorders,
  • Patients with mental disorders,
  • Patients with malignancy,
  • Patients with uncontrolled hypertension,
  • Patients with uncontrolled diabetes mellitus,
  • Patients with infection,
  • Patients who underwent surgery in the posterior cranial region and cervical vertebra.

Information from the National Library of Medicine

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


Contacts
Contact: Burcu Metin Ökmen, M.D. +902242955000 burcumetinokmen@gmail.com

Sponsors and Collaborators
Bursa Yüksek İhtisas Education and Research Hospital
Investigators
Principal Investigator: Burcu Metin Ökmen University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Responsible Party: Dr. Burcu Metin Ökmen, Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03459495     History of Changes
Other Study ID Numbers: 2011-KAEK-2018-1/25
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Burcu Metin Ökmen, Bursa Yüksek İhtisas Education and Research Hospital:
migraine, therapeutic ultrasound, pain, disability

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases