Efficacy of Manual Therapy in Migraine (MTHDIQMi)

May 15, 2015 updated by: GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia

DO SOFT TISSUE TECHNIQUES HAVE A POSITIVE EFFECT ON DISABILITY AND QUALITY OF LIFE IN MIGRAINE SUFFERERS?: A Randomized Controlled Trial

Objective: The aim of this study was to determine the efficacy of suboccipital inhibitory manual therapy treatment in migraine compared to treatment based on Myofascial Trigger Points (MTrPs) and their stretching, often being hypersensitive in patients with migraine.

Material and methods: 27 patients in two groups participated in the study: a) the control group received combined techniques based on MTrPs and bilateral stretching in the trapezius and sternocleidomastoid muscle (SCM); b) the experimental group was applied the same techniques as those applied in the control group plus suboccipital inhibition. The treatment lasted for 8 weeks and the impact, disability and quality of life were assessed in both groups.

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.

Detailed Description

Introduction Migraine is a highly prevalent disorder entailing substantial costs. Manual therapy offers an attractive option as an alternative to medical treatment or used in combination therewith. Treatment focused on the soft tissues of the suboccitpital region has been studied in other types of headaches but not in migraine.

Objective: The aim of this study was to determine the efficacy of suboccipital inhibitory manual therapy treatment in migraine compared to treatment based on Myofascial Trigger Points (MTrPs) and their stretching, often being hypersensitive in patients with migraine.

Material and methods: 27 patients in two groups participated in the study: a) the control group received combined techniques based on MTrPs and bilateral stretching in the trapezius and sternocleidomastoid muscle (SCM); b) the experimental group was applied the same techniques as those applied in the control group plus suboccipital inhibition. The treatment lasted for 8 weeks and the impact, disability and quality of life were assessed in both groups.

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.
30

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

  • Spain
      • Valencia, Spain, 46010
        • Gemma v. Espí López

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients were diagnosed according to the criteria established by the IHS

Exclusion Criteria:

  • Patients were excluded if they presented with other headache types, if their headache was triggered by neck movement, or if they presented with dizziness, hypertension, emotional stress, psychological disorders, cardiovascular disease or pregnancy.

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: Double

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: Sternocleidomastoid MTRP and stretching
The sternocleidomastoid was treated with ischemic compression.
Other: Trapezius MTRP and stretching
The central MTRP of the trapezius was treated as described above for the sternocleidomastoid. Subsequently stretching was performed, whereby the therapist supported the patient's head and performed passive contralateral inclination and ipsilateral rotation of the head. The therapist placed one hand over the patients shoulder while the other hand performed the stretching and simultaneously controlled the position of the head to achieve suitable stretching
Experimental: Trapezius MTRP and stretching
The central MTRP of the trapezius was treated as described above for the sternocleidomastoid.
Other: Sternocleidomastoid MTRP and stretching
The sternocleidomastoid was treated with ischemic compression. The patient's head was passively moved into contralateral rotation and the patient was asked to relax completely. Sustained pressure was then applied to the sternocleidomastoid muscle until the pain threshold was reached. During the application of pressure, pain decreases so the pressure was gradually increased over a duration of 1 minute. The pressure was then reduced progressively.

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
Pain intensity
Time Frame: 4 weeks
The Visual Analogue Scale (VAS)25 was used to rate the patients average pain intensity using a 0-10 scale (0=no pain, 10=the most severe pain).
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
The impact of headache (HIT-6)
Time Frame: 4 weeks
The Headache Impact Test (HIT-6) (Yang et al., 2011) provides an overall measure of the adverse impact of headaches. This questionnaire consists of 6 items measuring the impact of pain on social functioning, role functioning, vitality, cognitive functioning and psychological distress, and provides a measure of the severity.
4 weeks
Disability (MIDAS)
Time Frame: 4 weeks
. Disability caused by migraine was assessed by the MIDAS questionnaire (Adenis Silva et al., 2008) based on 5 questions and the score obtained from the sum of the days lost due to headaches registered in the questions.
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.
University of Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

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.
January 1, 2014

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.
November 1, 2014

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.
November 1, 2014

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).
March 20, 2015

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.
May 15, 2015

First Posted (Estimate)

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.
May 18, 2015

Study Record Updates

Last Update Posted (Estimate)

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.
May 18, 2015

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.
May 15, 2015

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.
May 1, 2015

More Information

Terms related to this study

Keywords

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.
  • ID005

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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