EFFECTS OF MIOFASCIAL RELEASE AND PERCUTANEOUS MICROELETROLYSIS IN TYPE HEADACHE (EMRPMITH)

July 18, 2017 updated by: Rodrigo Marcel Valentim da Silva

EFFECTS OF MIOFASCIAL RELEASE AND PERCUTANEOUS MICROELETROLYSIS IN INDIVIDUALS WITH TYPICAL TYPE HEADACHE

A headache is a more common disorder and one that prevails over a lifetime of much of the population. Among the causes are in the stress and spasms of the pericranial musculature, presence of painful sensitivity in the region, decrease of pain threshold, and a presence of trigger points (PGs) that can also cause as headaches. The solutions for health and health, in addition to Percutaneous Microelectrolysis (MEP®), which is used in the application of low intensity galvanic current through the acupuncture needle. Although it is a very common pathology, it is still little studied and a lack of information is a question of solutions such as crisis of care. This work justifies the negative bones of CTT in university students, as this has repercussions on the quality of life, besides proposing a therapeutic approach to reduce the symptomatology. The present study aims to investigate the effects of myofascial release techniques, MEP® and an association of therapies, observing the impact on quality of life and repercussions on academic performance. This is a controlled clinical trial of a convenience-based approach, consisting of universities between the 1st and 10th Physical Therapy course of Estácio Ponta Negra, over 18 years of age, who are not present in the application of the questionnaires, It is necessary to use the medicine of the analgesic type. The volunteers are evaluated through the HIT-6 and SF-36 questionnaires, after a selection of pain evaluation, PGs and algometry. The randomization will consist of 4 groups, after a consultation and an immediate re-evaluation and a second time and a new intervention and re-evaluation. A descriptive and inferential statistics will be performed through the SPSS 20.0 program. The normality of the data is observed by the Kolmogorov-Smirnov (KS) test. For a comparison between groups whose parametric data are applied or anova test with post hoc tukey comingue of significance of 5% (p <0.05). It is believed that the use of the association of myofascial release techniques and Percutaneous Microelectronics promotes greater benefits in tension headache.

Study Overview

Status

Status

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

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 (Anticipated)

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.
60

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Be over 18 years old, they will be present at the time of ordering, not being pregnant and not taking analgesic medication at least 24 hours before the intervention.

Exclusion Criteria:

  • More than 20% of the questionnaire data are incomplete and if during the research the volunteer presents some discomfort.

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: N/A
  • Interventional Model: Single Group 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: MEP® technique
G1 (n = 15), referred to as LMF, will be submitted to the myofascial release technique consisting of: classic massage (superficial sliding, deep sliding, pumping-kneading, pulse and four-finger smear and sliding) Minutes. G2 (n = 15) will be applied to the MEP® technique, in which the needles will be introduced in three occasions during each session, in different points of the musculature of the most painful region, for a total of 3 minutes. The G3 (n = 15) will execute the two techniques above, being applied the first version Myofascial and later to the MEP®. G4 (n = 15) will be the control group, not performing any of the interventions. The reevaluations will occur immediately and after 48 hours of the intervention.
Device: MEP® technique
G1 (n = 15), referred to as LMF, will be submitted to the myofascial release technique consisting of: classic massage (superficial sliding, deep sliding, pumping-kneading, pulse and four-finger smear and sliding) Minutes. G2 (n = 15) will be applied to the MEP® technique, in which the needles will be introduced in three occasions during each session, in different points of the musculature of the most painful region, for a total of 3 minutes. The G3 (n = 15) will execute the two techniques above, being applied the first version Myofascial and later to the MEP®. G4 (n = 15) will be the control group, not performing any of the interventions. The reevaluations will occur immediately and after 48 hours of the intervention.
Other Names:
  • classic massage (superficial sliding, deep sliding, pumping-kneading, pulse and four-finger smear and sliding)

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
Headache impact test (HIT-6)
Time Frame: ten minutes
This is composed of six questions, with scores ranging from six to 13 points, which can total between 36-78 points; So the higher this score, the greater the impact of headache on the daily activities of the individual.
ten minutes
Quality of life assessment (SF-36)
Time Frame: ten minutes
Validated and adapted to the Brazilian culture. This allows to compare the quality of life of healthy individuals and patients of different pathologies. It consists of 36 questions, which encompass 8 components: functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects and mental health. The final score can vary from 0 (worst general health condition) to 100 (better health).
ten minutes
Pain assessment
Time Frame: five minutes
To grade the pain before the intervention will be applied the visual analogue scale. It is a subjective test in which the volunteer will self-evaluate. It will be performed with a horizontal line in which the beginning will represent absence of pain and at the end of the line will represent the maximum pain, and will be oriented to mark in the line the perception of the pain at that moment.
five minutes
Evaluation of trigger points
Time Frame: twenty minutes
The presence of trigger points in the upper trapezius, sternocleidomastoid, suboccipital and splenius muscles of the neck will be investigated. Localization along the tense muscle band to the presence of palpable nodules, local pain to the digital compression (estimated time of 6 s) of a palpable nodule located in a tight band; Recognition of pain referred by the patient as familiar by pressing the sensitive nodule (to identify active PG)
twenty minutes
Assessment of pressure pain threshold
Time Frame: twenty minutes
To evaluate the pain threshold, a WAGNER FDX algometer will be used, which is a device consisting of a rubber disk measuring 1 cm2 connected to a pressure gauge, which has values in kgf / cm2. The upper trapezius muscle will be evaluated at the mean distance between the C7 and the acromion of the scapula along its fibers. If the algometry evaluation point coincides with the trigger point, the analysis with the algometer will be performed 2 cm apart in the medial to the point direction.
twenty minutes

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.
Rodrigo Marcel Valentim da Silva

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 (Anticipated)

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.
August 20, 2017

Primary Completion (Anticipated)

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 20, 2017

Study Completion (Anticipated)

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.
January 30, 2018

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).
June 11, 2017

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.
July 18, 2017

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.
July 21, 2017

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.
July 21, 2017

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.
July 18, 2017

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.
July 1, 2017

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.
  • RSilva

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

product manufactured in and exported from the U.S.

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.

Clinical Trials on Tension-Type Headache

Clinical Trials on MEP® technique

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings