Therapeutic Ultrasound in the Treatment of Migraine

NCT ID: NCT03459495

Last Updated: 2019-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-10

Study Completion Date

2018-12-10

Brief Summary

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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

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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.

Conditions

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Migraine Ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective,randomized,placebo- controlled, double blind
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

Group A: ultrasound group

Group Type ACTIVE_COMPARATOR

therapeutic ultrasound

Intervention Type DEVICE

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

Group P

Group P: placebo ultrasound group

Group Type PLACEBO_COMPARATOR

placebo ultrasound

Intervention Type DEVICE

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.

Interventions

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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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Burcu Metin Ökmen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Burcu Metin Ökmen

Role: PRINCIPAL_INVESTIGATOR

Bursa Yuksek Ihtisas Training and Research Hospital

Locations

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Burcu Metin Ökmen

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2011-KAEK-2018-1/25

Identifier Type: -

Identifier Source: org_study_id

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