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

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
IASTM
home exercise
Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom)
Sponsored by
Emine Atıcı
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Emine Atıcı

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control Group

IASTM (instrument-assisted soft tissue mobilization)

OTES (Occipital Transcutenous Electric Stimulation)

Arm Description

participants were given home exercise (once a day for 5 weeks)

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.

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.

Outcomes

Primary Outcome Measures

Visuel Analog Skale
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

Secondary Outcome Measures

Headache effect test (HIT-6)
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
Pittsburgh sleep quality index (PQI)
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
SF 36
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

Full Information

First Posted
April 28, 2022
Last Updated
May 12, 2022
Sponsor
Emine Atıcı
Collaborators
KTO Karatay University
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1. Study Identification

Unique Protocol Identification Number
NCT05372796
Brief Title
The Effects of Transcutaneous Occipital Nerve Stimulation and Instrument-Assisted Soft Tissue Mobilization on Patients With Chronic Migraine
Official Title
Effects of Transcutaneous Occipital Nerve Stimulation and Instrument-Assisted Soft Tissue Mobilization in Chronic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
February 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emine Atıcı
Collaborators
KTO Karatay University

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Experimental
Arm Description
participants were given home exercise (once a day for 5 weeks)
Arm Title
IASTM (instrument-assisted soft tissue mobilization)
Arm Type
Experimental
Arm Description
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.
Arm Title
OTES (Occipital Transcutenous Electric Stimulation)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
IASTM
Intervention Description
instrument-assisted soft tissue mobilization
Intervention Type
Other
Intervention Name(s)
home exercise
Intervention Description
home exercise
Intervention Type
Device
Intervention Name(s)
Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom)
Intervention Description
OTES (Occipital Transcutenous Electric Stimulation)
Primary Outcome Measure Information:
Title
Visuel Analog Skale
Description
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
Time Frame
Change from Baseline Pain at 5 weeks
Secondary Outcome Measure Information:
Title
Headache effect test (HIT-6)
Description
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
Time Frame
Change from baseline headache at 5 weeks
Title
Pittsburgh sleep quality index (PQI)
Description
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
Time Frame
change from baseline sleep at 5 weeks
Title
SF 36
Description
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
Time Frame
Change from baseline quality of life at 5 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Emine Atıcı
City
Tuzla
State/Province
İstanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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