Therapeutic Ultrasound in the Treatment of Migraine

NCT03459495 | Completed

• 1 other identifier: 2011-KAEK-2018-1/25
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Ultrasound

Keywords

migraine, therapeutic ultrasound, pain, disability

Outcome Measures

Primary Outcomes (2)

• 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).

  4 months

• 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

  4 months

Secondary Outcomes (2)

• paracetamol consumption

  4 months

• the number of migraine attacks per month.

  4 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A: ultrasound group

Device: therapeutic ultrasound

Group P

PLACEBO COMPARATOR

Group P: placebo ultrasound group

Device: placebo ultrasound

Interventions

therapeutic ultrasound 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 A

placebo ultrasound 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.

Group P

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Burcu Metin Ökmen

Bursa, 16330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders; Pain

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Officials

• Burcu Metin Ökmen

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: prospective,randomized,placebo- controlled, double blind

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 9, 2018
• Study Start: March 10, 2018
• Primary Completion: September 10, 2018
• Study Completion: December 10, 2018
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

TU (1)