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

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: Unknown
• Conditions: Tension-Type Headache; Trigger Point
• Intervention / Treatment: Device: MEP® technique

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rodrigo M Valentim da Silva, Doctor; Phone Number: 55 (084) 999517077; Email: marcelvalentim@hotmsil.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Headache impact test (HIT-6)	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)	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	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	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	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

• Sponsor: Rodrigo Marcel Valentim da Silva

Study record dates

Study Major Dates

• Study Start (Anticipated): August 20, 2017
• Primary Completion (Anticipated): December 20, 2017
• Study Completion (Anticipated): January 30, 2018

Study Registration Dates

• First Submitted: June 11, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Physiotherapy; Percutaneous microelectrolysis
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID 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