NCT03225053

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 20, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

4 months

First QC Date

June 11, 2017

Last Update Submit

July 18, 2017

Conditions

Keywords

Percutaneous microelectrolysisPhysiotherapy

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

MEP® technique

EXPERIMENTAL

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

Interventions

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.

Also known as: classic massage (superficial sliding, deep sliding, pumping-kneading, pulse and four-finger smear and sliding)
MEP® technique

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Central Study Contacts

Rodrigo M Valentim da Silva, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2017

First Posted

July 21, 2017

Study Start

August 20, 2017

Primary Completion

December 20, 2017

Study Completion

January 30, 2018

Last Updated

July 21, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share