MigraineNCT05372796
The Effects of Transcutaneous Occipital Nerve Stimulation and Instrument-Assisted Soft Tissue Mobilization on Patients With Chronic Migraine
A study testing IASTM, home exercise and Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom) in people with Migraine, run by Emine Atıcı at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Migraine
- What is being tested?
- IASTM, home exercise and Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 26 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Migraine
- Being tested
- IASTM, home exercise, Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom)
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IASTMOther
instrument-assisted soft tissue mobilization
home exerciseOther
home exercise
Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom)Device
OTES (Occipital Transcutenous Electric Stimulation)
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | participants were given home exercise (once a day for 5 weeks) Receives: Other: home exercise |
| IASTM (instrument-assisted soft tissue mobilization) | Experimental | 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. Receives: Other: IASTM |
| OTES (Occipital Transcutenous Electric Stimulation) | Experimental | 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. Receives: Device: Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline Pain at 5 weeks
Secondary outcomes (3)
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
Measured: Change from baseline headache at 5 weeks
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
Measured: change from baseline sleep at 5 weeks
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
Measured: Change from baseline quality of life at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start1 Sep 2021
- Primary completion30 Jan 2022
- Study completion26 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emine Atıcı
- Sponsor type
- University, hospital or other
- Collaborators
- KTO Karatay University
- Responsible party
- Sponsor-investigator, Emine Atıcı, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372796
- Sponsor's protocol ID
- 007
- Status last verified
- May 2022
- First submitted
- 28 Apr 2022
- Last updated
- 13 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Occipital Nerve Stimulation and Instrument-Assisted Soft Tissue Mobilization in Chronic Migraine
- ClinicalTrials.gov ID
- NCT05372796
- Acronym / sponsor ID
- 007
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Emine AtıcıUniversity, hospital or other
- Collaborators
- KTO Karatay University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 26 Feb 2022 (actual)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: home exerciseparticipants were given home exercise (once a day for 5 weeks) |
| IASTM (instrument-assisted soft tissue mobilization) | Experimental | Other: IASTMIASTM 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. |
| OTES (Occipital Transcutenous Electric Stimulation) | Experimental | Device: Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom)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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IASTMinstrument-assisted soft tissue mobilization | Other | IASTM (instrument-assisted soft tissue mobilization) |
| home exercisehome exercise | Other | Control Group |
| Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom)OTES (Occipital Transcutenous Electric Stimulation) | Device | OTES (Occipital Transcutenous Electric Stimulation) |
Primary outcome
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
3 secondary outcomes
Headache effect test (HIT-6)
Time frame: Change from baseline headache at 5 weeks
Pittsburgh sleep quality index (PQI)
Time frame: change from baseline sleep at 5 weeks
SF 36
Time frame: Change from baseline quality of life at 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IASTM, home exercise and Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom) in people with Migraine, run by Emine Atıcı at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visuel Analog Skale (time frame: Change from Baseline Pain at 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.