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CompletedNCT03459495Updated Jul 23, 2019

Therapeutic Ultrasound in the Treatment of Migraine

An interventional study of therapeutic ultrasound and placebo ultrasound in Migraine and Ultrasound, sponsored by Bursa Yüksek İhtisas Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-07-23.

Sponsored by Bursa Yüksek İhtisas Education and Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Migraine
  • Ultrasound

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Keywords

  • migraine, therapeutic ultrasound, pain, disability
03

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
58 participants (actual)

Study arms

  • Active comparator
    Group A

    Group A: ultrasound group

    Device: therapeutic ultrasound

  • Placebo comparator
    Group P

    Group P: placebo ultrasound group

    Device: placebo ultrasound

Interventions

  • Devicetherapeutic 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

  • Deviceplacebo 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.

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 4 months

  2. 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

    Time frame: 4 months

Secondary outcomes

  1. paracetamol consumption

    Time frame: 4 months

  2. the number of migraine attacks per month.

    Time frame: 4 months

06

Study locations

1 site
  • Burcu Metin Ökmen
    Bursa, 16330, Turkey
07

Registry details

Key details

Study ID
NCT03459495
Lead sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Responsible party
Dr. Burcu Metin Ökmen (Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital) — Principal investigator
First posted
Mar 9, 2018
Start date
Mar 10, 2018
Primary completion
Sep 10, 2018
Completion
Dec 10, 2018
Last update
Jul 23, 2019

Study contacts

Burcu Metin Ökmen
principal investigator · UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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