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Therapeutic Ultrasound in the Treatment of Migraine

Primary Purpose

Migraine, Ultrasound

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
therapeutic ultrasound
placebo ultrasound
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring migraine, therapeutic ultrasound, pain, disability

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Burcu Metin Ökmen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group A

Group P

Arm Description

Group A: ultrasound group

Group P: placebo ultrasound group

Outcomes

Primary Outcome Measures

Numeric rating scale (NRS)
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)
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

paracetamol consumption
the number of migraine attacks per month.

Full Information

First Posted
March 1, 2018
Last Updated
July 22, 2019
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03459495
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 10, 2018 (Actual)
Primary Completion Date
September 10, 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Yüksek İhtisas Education and Research Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Ultrasound
Keywords
migraine, therapeutic ultrasound, pain, disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective,randomized,placebo- controlled, double blind
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Group A: ultrasound group
Arm Title
Group P
Arm Type
Placebo Comparator
Arm Description
Group P: placebo ultrasound group
Intervention Type
Device
Intervention Name(s)
therapeutic ultrasound
Intervention Description
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
Intervention Name(s)
placebo ultrasound
Intervention Description
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 Measure Information:
Title
Numeric rating scale (NRS)
Description
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).
Time Frame
4 months
Title
Migraine Disability Assessment Questionnaire Score (MIDAS)
Description
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
Time Frame
4 months
Secondary Outcome Measure Information:
Title
paracetamol consumption
Time Frame
4 months
Title
the number of migraine attacks per month.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcu Metin Ökmen
Organizational Affiliation
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burcu Metin Ökmen
City
Bursa
ZIP/Postal Code
16330
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Therapeutic Ultrasound in the Treatment of Migraine

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