NCT05372796

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
Last Updated

May 13, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

April 28, 2022

Last Update Submit

May 12, 2022

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • 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

    Change from Baseline Pain at 5 weeks

Secondary Outcomes (3)

  • Headache effect test (HIT-6)

    Change from baseline headache at 5 weeks

  • Pittsburgh sleep quality index (PQI)

    change from baseline sleep at 5 weeks

  • SF 36

    Change from baseline quality of life at 5 weeks

Study Arms (3)

Control Group

EXPERIMENTAL

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

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.

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.

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

Interventions

IASTMOTHER

instrument-assisted soft tissue mobilization

IASTM (instrument-assisted soft tissue mobilization)
home exerciseOTHER

home exercise

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

OTES (Occipital Transcutenous Electric Stimulation)

OTES (Occipital Transcutenous Electric Stimulation)

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emine Atıcı

Tuzla, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 13, 2022

Study Start

September 1, 2021

Primary Completion

January 30, 2022

Study Completion

February 26, 2022

Last Updated

May 13, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)