NCT04171362

Brief Summary

The aim of this study was to investigate the effectiveness of connective tissue massage in patients with migraine

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

September 7, 2020

Status Verified

November 1, 2019

Enrollment Period

9 months

First QC Date

November 18, 2019

Last Update Submit

September 4, 2020

Conditions

Migraine With AuraMigraineMigraine Without AuraConnective Tissue Diseases

Outcome Measures

Primary Outcomes (1)

  • Migraine Disability Assessment Test

    To assess the level of disability of patients Migraine Disability Assessment Test (MIDAS) was used. It is a widely used and validated test. MIDAS was translated into Turkish and validity and reliability studies were conducted. MIDAS is a test filled in by patients that identifies migraine disability in all areas of activity during last 3 months.It consists of 5 questions.The total MIDAS score is the sum of the days given as response to these five questions (MIDAS 1 to MIDAS 5). The total score ranges from 0 to 90 and is used to categorize patients in disability grades I to IV. A higher score means more severe disability, placing the patient in a higher disability grade

    change from baseline at 4 weeks

Secondary Outcomes (4)

  • Pittsburgh Sleep Quality Index

    change from baseline at 4 weeks

  • Hospital Anxiety and Depression Scale (

    change from baseline at 4 weeks

  • Nothingham Health Profile

    Before the treatment and end of 4 weeks

  • Allodynia Symptom Checklist

    change from baseline at 4 weeks

Study Arms (2)

Migraine group

EXPERIMENTAL

The study included patients diagnosed by migraine according to International Headache Community criteria with18-65 years of age followed by routine controls and who were volunteered

Other: Connective Tissue MassageOther: Education

Control group

ACTIVE COMPARATOR

The study included patients diagnosed by migraine according to International Headache Community criteria with 8-65 years of age followed by routine controls and were volunteered

Other: Education

Interventions

Connective Tissue MassageOTHER

Connective tissue massage (CTM) is a manipulative technique that facilitates the diagnosis and treatment of a wide range of pathologies. Observation and subsequent manipulation of the skin and subcutaneous tissues can have a beneficial effect upon tissues remote from the area of treatment.

Migraine group
EducationOTHER

Education patients were informed about migraine triggers, migraine prevention and coping strategies and exercise options. The exercises were demonstrated by the physiotherapist

Control groupMigraine group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Migraine Disease
  • Being volunteer

You may not qualify if:

  • Serious psychiatric problems with mental and / or communication problems Neurological, inflammatory or endocrine disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özge Çoban

Ankara, 06760, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine with AuraMigraine DisordersMigraine without AuraConnective Tissue Diseases

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 20, 2019

Study Start

March 28, 2019

Primary Completion

December 10, 2019

Study Completion

December 20, 2019

Last Updated

September 7, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)