The Effects of Transcutaneous Occipital Nerve Stimulation and Instrument-Assisted Soft Tissue Mobilization on Patients With Chronic Migraine

May 12, 2022 updated by: Emine Atıcı

Effects of Transcutaneous Occipital Nerve Stimulation and Instrument-Assisted Soft Tissue Mobilization in Chronic Migraine

In this study, it was aimed to examine the effects of two different treatments applied to the neck region, which have been popular in recent years, on migraine.The study included 45 female patients aged 20-50 years with migraine complaints. The patients were divided into 3 randomized groups: control group (n=15), Instrument-Assisted Soft tissue Mobilization (EDYDM) group (n=15) and on Occipital nerve TENS (OTES) group(n=15).Each group was given home exercise to their treatment. Home exercises applied 1 time per day for 5 weeks. Each exercise in the exercise program was performed with 10 repetitions

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İstanbul
      • Tuzla, İstanbul, Turkey
        • Emine Atıcı

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Be between the ages of 20-50
  • International Classification of headache disorders, Third Edition (beta), using the criteria to be diagnosed with migraine without aura,
  • migraine with a history of being at least an annual,
  • VAS neck pain to be on Level 4,
  • the hit-6 score is greater than 56

Exclusion Criteria:

  • receiving pharmacological or non-pharmacological treatment regularly in the last three months,
  • using a pacemaker,
  • being an epileptic or severely psychiatric patient,
  • conducting a surgical operation from the neck region,
  • cervical disc degeneration or prolapse, the presence of different diagnoses of headaches

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Control Group
participants were given home exercise (once a day for 5 weeks)
Other: home exercise
home exercise
Experimental: IASTM (instrument-assisted soft tissue mobilization)
IASTM was applied to the patients (M. Sternocleidomastoideus, M. Trapezius, M. Paraspinales and M. Levator Scapula) in the IASTM group twice a week for 5 weeks.
Other: IASTM
instrument-assisted soft tissue mobilization
Experimental: OTES (Occipital Transcutenous Electric Stimulation)
Participants in the OTES group were treated with a Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom) 3 times a week for 5 weeks. Four self-adhesive 40*40 mm sized electrodes were attached to the occipital region of the patients bilaterally, covering the occipital nerves. The current intensity was adjusted according to the patient. The current intensity started from 0 mA and the current intensity was increased one by one every 30 seconds, the patient was allowed to tolerate the current by giving current without muscle twitching or harmful stimulation. The current frequency was determined as 2/100 Hz. Square waves at 2 Hz were applied for 3 seconds followed by an automatic shift to 100 Hz for another 3 seconds.
Device: Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom)
OTES (Occipital Transcutenous Electric Stimulation)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visuel Analog Skale
Time Frame: Change from Baseline Pain at 5 weeks
VAS is a one-dimensional scale used to determine the severity of pain. The patient is asked to mark the pain he feels on a straight line of 10 cm. the value '0" means that there is no pain at all, and the value "10" means the most severe pain
Change from Baseline Pain at 5 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Headache effect test (HIT-6)
Time Frame: Change from baseline headache at 5 weeks
The Headache Impact Test-6 (HIT-6) has been developed to measure the factors contributing to headache and provides quantitative information about the impact of headache. HIT-6 consists of 6 items: pain, social functioning, role function, vitality, cognitive function and psychological distress. Scores ranging from 36 to 78 are obtained from the test Dec High scores indicate that the patient's headache negatively affects his daily life
Change from baseline headache at 5 weeks
Pittsburgh sleep quality index (PQI)
Time Frame: change from baseline sleep at 5 weeks
The Pittsburgh sleep quality index (PQI) consists of 24 questions in total. The individual himself answers 19 of these questions. The remaining five questions are answered by the person staying with him, if the person is left alone, they are evaluated for informational purposes and are not added as scoring. There are seven dimensions in the index, namely subjective sleep quality, sleep latency, sleep duration, habitual sleep pattern, sleep disorder status, drug use to fall asleep, daytime dysfunction. The question of each dimension Dec a score between 0 and 3. A total score of 7 dimensions in total gives a sleep quality score. The total score is the range from 0 to 21. The sleep quality of people with a score total below 5 is 'good'; for those with more than 5, their sleep quality is interpreted as 'bad
change from baseline sleep at 5 weeks
SF 36
Time Frame: Change from baseline quality of life at 5 weeks
The SF-36 quality of life index is a scale that evaluates a person's general health status. 2 basic parameters (mental and physical) and 8 sub-parameter (emotional function, physical function, physical role, social function, mental health, general health, vitality, and pain) to rate on the total consists of 36 questions. From 0 to 100 points can be obtained from each parameter. High scores indicate that a person's quality of life is good
Change from baseline quality of life at 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emine Atıcı

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KTO Karatay University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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