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

This study is not yet open for participant recruitment.
Verified July 2017 by Rodrigo Marcel Valentim da Silva, Estácio Ponta Negra
Sponsor:
ClinicalTrials.gov Identifier:
NCT03225053
First Posted: July 21, 2017
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rodrigo Marcel Valentim da Silva, Estácio Ponta Negra
  Purpose
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.

Condition Intervention
Trigger Point Tension-Type Headache Device: MEP® technique

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
After the initial evaluation, the investigator 2 will conduct the experimental procedures in the different groups, which will be submitted to the following protocols: G1 (n = 15) called LMF will be submitted to the myofascial release technique consisting of: , Deep sliding, pumping-kneading, thumb and four-finger rubbing, and sliding) applied to the musculature of the most painful region for 15 minutes. G2 (n = 15) will be applied to the MEP® technique, in which needles will be introduced on three occasions during each session, at different points of the musculature of the most painful region, for a total of 3 minutes. The G3 (n = 15) will be performed the two techniques above, being applied first Miofascial Release and later to 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EFFECTS OF MIOFASCIAL RELEASE AND PERCUTANEOUS MICROELETROLYSIS IN INDIVIDUALS WITH TYPICAL TYPE HEADACHE

Resource links provided by NLM:


Further study details as provided by Rodrigo Marcel Valentim da Silva, Estácio Ponta Negra:

Primary Outcome Measures:
  • 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.

  • 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).

  • 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.

  • 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)

  • 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.


Estimated Enrollment: 60
Anticipated Study Start Date: August 20, 2017
Estimated Study Completion Date: January 30, 2018
Estimated Primary Completion Date: December 20, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: classic massage (superficial sliding, deep sliding, pumping-kneading, pulse and four-finger smear and sliding)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225053


Contacts
Contact: Rodrigo M Valentim da Silva, Doctor 55 (084) 999517077 marcelvalentim@hotmsil.com

Sponsors and Collaborators
Rodrigo Marcel Valentim da Silva
  More Information

Responsible Party: Rodrigo Marcel Valentim da Silva, Principal Investigator, Estácio Ponta Negra
ClinicalTrials.gov Identifier: NCT03225053     History of Changes
Other Study ID Numbers: RSilva
First Submitted: June 11, 2017
First Posted: July 21, 2017
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Rodrigo Marcel Valentim da Silva, Estácio Ponta Negra:
Percutaneous microelectrolysis
Physiotherapy

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases