Clinical trial NCT03459495: Therapeutic Ultrasound in the Treatment of Migraine
Official title: Investigation of the Efficacy of Therapeutic Ultrasound in the Treatment of Migraine; Prospective, Randomized, Placebo Controlled, Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Ultrasound
Keywords: migraine, therapeutic ultrasound, pain, disability
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-03-09
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective,randomized,placebo- controlled, double blind
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Numeric rating scale (NRS)
timeFrame: 4 months
measure: Migraine Disability Assessment Questionnaire Score (MIDAS)
timeFrame: 4 months
Secondary outcomes:
measure: paracetamol consumption
timeFrame: 4 months
measure: the number of migraine attacks per month.
timeFrame: 4 months
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Burcu Metin Ökmen
Study officials:
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Burcu Metin Ökmen
role: PRINCIPAL_INVESTIGATOR
References: