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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372796
• Other study ID #: 007
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: February 26, 2022

Study information

• Verified date: May 2022
• Source: Okan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 26, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Other:
• IASTM
instrument-assisted soft tissue mobilization
• home exercise
home exercise

Device:
• Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom)
OTES (Occipital Transcutenous Electric Stimulation)

Locations

Country	Name	City	State
Turkey	Emine Atici	Tuzla	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Emine Atici	KTO Karatay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Change from baseline headache at 5 weeks
Secondary	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	change from baseline sleep at 5 weeks
Secondary	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	Change from baseline quality of life at 5 weeks