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

NCT ID: NCT05372796

Last Updated: 2022-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-02-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

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

Group Type EXPERIMENTAL

home exercise

Intervention Type OTHER

home exercise

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.

Group Type EXPERIMENTAL

IASTM

Intervention Type OTHER

instrument-assisted soft tissue mobilization

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.

Group Type EXPERIMENTAL

Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom)

Intervention Type DEVICE

OTES (Occipital Transcutenous Electric Stimulation)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IASTM

instrument-assisted soft tissue mobilization

Intervention Type OTHER

home exercise

home exercise

Intervention Type OTHER

Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom)

OTES (Occipital Transcutenous Electric Stimulation)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

KTO Karatay University

OTHER

Sponsor Role collaborator

Emine Atıcı

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emine Atıcı

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Emine Atıcı

Tuzla, Istanbul, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.