The Effect of Connective Tissue Massage in Patients With Migraine

September 4, 2020 updated by: Ankara Yildirim Beyazıt University
The aim of this study was to investigate the effectiveness of connective tissue massage in patients with migraine

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06760
        • Özge Çoban

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Migraine Disease
  • Being volunteer

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Migraine group
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 Massage
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.
Other: Education
Education patients were informed about migraine triggers, migraine prevention and coping strategies and exercise options. The exercises were demonstrated by the physiotherapist
Active Comparator: Control group
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
Education patients were informed about migraine triggers, migraine prevention and coping strategies and exercise options. The exercises were demonstrated by the physiotherapist

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Migraine Disability Assessment Test
Time Frame: change from baseline at 4 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index
Time Frame: change from baseline at 4 weeks
Pittsburgh Sleep Quality Index to evaluate sleep quality (PSQI) will be used. It is a reliable and valid scale with 19 questions to assess the presence and severity of the disorder. The questionnaire was adapted to Turkish patients by Ağargün et al. The scale can measure subjective sleep quality, sleep latency, sleep time, sleep efficiency, sleep disturbance, sleep medication use and daytime work. The response of each is scored as 0-3. Having a global score of 5 or higher, indicates bad sleep quality.
change from baseline at 4 weeks
Hospital Anxiety and Depression Scale (
Time Frame: change from baseline at 4 weeks
Hospital Anxiety and Depression Scale (HADS) will be usedl to assess the anxiety and depression. Validity and reliability of HADS in Turkish was established by Aydemir et al. This scale consists of 14 questions. Half of questions (odd numbers) measures anxiety and the other half (even numbers) measures depression. Answers quartet likert format and are scored between 0-3. The lowest score they can get from the sub-scale is 0, the highest score is 21 for each subscale. 10 point is considered as a treshold for depression and or anxiety.
change from baseline at 4 weeks
Nothingham Health Profile
Time Frame: Before the treatment and end of 4 weeks
Nothingham Health Profile was used to measure quality of life. Nottingham Health Profile, emotional, physical and social problems survey. The Turkish validity was made in 1997 by Küçükdeveci et al.There are 6 sub-sections in the survey which consists of 38 questions in total. These sections include pain (8 questions), physical activity (8 questions),fatigue (3 questions), sleep (5 questions), social isolation (5 questions) and emotional reactions (9 questions) the participant is asked to answer these questions in the form of yes or no. Total score for each section scored as 0-100."0 points" indicates the best health status, "100 points indicates the worst health status.
Before the treatment and end of 4 weeks
Allodynia Symptom Checklist
Time Frame: change from baseline at 4 weeks
To evaluate allodynia symptoms associated with headache attacks "Allodynia Symptom Checklist" will be used. 12 different situations are questioned in this list. Each situations are scored as "does not apply to me", "never", "rarely", "less than half", "half or more often". ITotal score ranged between 0-24 points.
change from baseline at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-22.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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