Trigger PointEMRPMITHNCT03225053
EFFECTS OF MIOFASCIAL RELEASE AND PERCUTANEOUS MICROELETROLYSIS IN TYPE HEADACHE
A study testing MEP® technique in people with Trigger Point and Tension-Type Headache, run by Rodrigo Marcel Valentim da Silva.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Trigger Point, Tension-Type Headache
- What is being tested?
- MEP® technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2017to 30 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- More than 20% of the questionnaire data are incomplete and if during the research the volunteer presents some discomfort.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Trigger Point, Tension-Type Headache
- Being tested
- MEP® technique
- Keywords
- Percutaneous microelectrolysis, Physiotherapy
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEP® techniqueDevice
Also called classic massage (superficial sliding, deep sliding, pumping-kneading, pulse and four-finger smear and sliding)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MEP® technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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.
Measured: twenty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start20 Aug 2017 (estimated)
- Primary completion20 Dec 2017 (estimated)
- Study completion30 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger PointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rodrigo Marcel Valentim da Silva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rodrigo Marcel Valentim da Silva, Estácio Ponta Negra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225053
- Sponsor's protocol ID
- RSilva
- Acronym
- EMRPMITH
- Status last verified
- Jul 2017
- First submitted
- 11 Jun 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF MIOFASCIAL RELEASE AND PERCUTANEOUS MICROELETROLYSIS IN INDIVIDUALS WITH TYPICAL TYPE HEADACHE
- ClinicalTrials.gov ID
- NCT03225053
- Acronym / sponsor ID
- EMRPMITH / RSilva
- Conditions
- Trigger Point, Tension-Type Headache
- Keywords
- Percutaneous microelectrolysis, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rodrigo Marcel Valentim da SilvaUniversity, hospital or other
- Study start
- 20 Aug 2017 (estimated)
- Primary completion
- 20 Dec 2017 (estimated)
- Study completion
- 30 Jan 2018 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| MEP® technique | Experimental | Device: MEP® techniqueG1 (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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- More than 20% of the questionnaire data are incomplete and if during the research the volunteer presents some discomfort.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEP® techniqueAlso: classic massage (superficial sliding, deep sliding, pumping-kneading, pulse and four-finger smear and sliding)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 |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing MEP® technique in people with Trigger Point and Tension-Type Headache, run by Rodrigo Marcel Valentim da Silva.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo M Valentim da Silva, Doctor (55 (084) 999517077, marcelvalentim@hotmsil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache impact test (HIT-6) (time frame: ten minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.