Neck Pain, PosteriorNCT05524623
Comparative Effect of MEP With or Without Current Emission in the Treatment of Cervical Pain in MTrPs of the Trapezius
A study testing percutaneous microelectrolysis in myofascial trigger points of the trapezius in people with Neck Pain, Posterior and Myofascial Pain Syndromes, run by Universidad Nacional de Córdoba at 1 site in Argentina.
Trial summary
Myofascial pain syndrome (MPS) is initial to other pathologies such as neck pain or tension headaches; the symptoms that are located on the area of myofascial trigger points (MTrPs) of specific references in different muscles. MTrPs are palpable, tense bands found in stiff muscle that cause pain and swelling. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Neck Pain, Posterior, Myofascial Pain Syndromes
- What is being tested?
- percutaneous microelectrolysis in myofascial trigger points of the trapezius
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteArgentina
- Study dates
- 16 Aug 2022to 30 Mar 2023
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- with medical referral for pain of at least 1 month of evolution
- presenting on both sides of the trapezius MTrPs muscle
Who cannot join
- neck pain who do currently receive physiotherapeutic treatment of at least 1 month of evolution
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Centro de Investigación, Extensión y Capacitación de la Escuela de Kinesiología y Fisioterapia
Córdoba, 5000
About this study
Official title: Comparative Effect of Percutaneous Microelectrolysis With or Without Current Emission in the Treatment of Cervical Pain in Myofascial Trigger Points of the Trapezius
Myofascial pain syndrome (MPS) is initial to other pathologies such as neck pain or tension headaches; the symptoms that are located on the area of myofascial trigger points (MTrPs) of specific references in different muscles. MTrPs are palpable, tense bands found in stiff muscle that cause pain and swelling. They affect the disruptive soft tissues, resulting in deterioration of the muscle and fascia; effects that can be transferred further, through the myofascial chain to distant tissues, inducing the referred pain that is the main feature of MPS. MTrPs are treated with stretching, massage, analgesics, acupuncture, dry needling, electrical stimulation, and ultrasound. Percutaneous microelectrolysis (MEP®) is a new technique that uses galvanic current of low intensity and high density. Based on the previous reviews, the investigators consider that the use of MEP in individuals who have MTrPs in the trapezius is more effective than acupuncture treatment. Objectives: To assess the effect of MEP as a technique for treating pain in MTrPs of the trapezius muscle compared to without current emission, analyzing function, pain and strength in MTrPs before and after both treatments.
Read the detailed description
Myofascial pain syndrome (MPS) is initial to other pathologies such as neck pain or tension headaches; the symptoms that are located on the area of myofascial trigger points (MTrPs) of specific references in different muscles. MTrPs are palpable, tense bands found in stiff muscle that cause pain and swelling. They affect the disruptive soft tissues, resulting in deterioration of the muscle and fascia; effects that can be transferred further, through the myofascial chain to distant tissues, inducing the referred pain that is the main feature of MPS. MTrPs are treated with stretching, massage, analgesics, acupuncture, dry needling, electrical stimulation, and ultrasound. Percutaneous microelectrolysis (MEP®) is a new technique that uses galvanic current of low intensity and high density. Based on the previous reviews, the investigators consider that the use of MEP in individuals who have MTrPs in the trapezius is more effective than acupuncture treatment. Objectives: To assess the effect of MEP as a technique for treating pain in MTrPs of the trapezius muscle compared to without current emission, analyzing function, pain and strength in MTrPs before and after both treatments.
Materials and methods: Randomized controlled clinical research. The study population consists of patients of both sexes between 20 and 60 years of age, with medical referral for neck pain who do not currently receive physiotherapeutic treatment, pain of at least 1 month of evolution, presenting on both sides of the trapezius MTrPs muscle and having signed the informed consent. They will be randomly distributed into: group treated with acupuncture (control) and group treated with MEP. Both will take place over 3 weeks, with one session per week. The evaluation is carried out through the visual analogue scale (VAS), measurement of force with a dynamometer and mobility with a goniometer. The score will be recorded on a validated neck pain questionnaire (NPQ). The Chi-Square test (test) will be implemented for the analysis of categorical data and the \"t\" test for paired data for quantitative data, based on a significance level of p˂0.05 in all cases.
- Conditions
- Neck Pain, Posterior, Myofascial Pain Syndromes
- Being tested
- percutaneous microelectrolysis in myofascial trigger points of the trapezius
- Keywords
- neck, pain, muscles, needles, Electrolysis, electrotherapy
- Medical subject headings
- Neck Pain, Myofascial Pain Syndromes, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous microelectrolysis in myofascial trigger points of the trapeziusOther
Also called MEP (percutaneous microelectrolysis), Trigger Points
percutaneous microelectrolysis with or without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius
| Study group | Role | What they receive |
|---|---|---|
| without current emission in the treatment | Sham comparator | percutaneous microelectrolysis without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius. Both will take place over 3 weeks, with one session per week. Receives: Other: percutaneous microelectrolysis in myofascial trigger points of the trapezius |
| wit current emission in the treatment | Active comparator | percutaneous microelectrolysis with current emission in the treatment of cervical pain in myofascial trigger points of the trapezius. oth will take place over 3 weeks, with one session per week. Receives: Other: percutaneous microelectrolysis in myofascial trigger points of the trapezius |
What is being measured
The primary outcome is the main question the study is designed to answer.
Northwick Park Neck Pain Questionnaire
The validated and adapted Northwick Park Neck Pain Questionnaire (NPQ) relates to activities of daily living. The outcome measure is in Points per NPQ protocol. The questionnaire will be completed prior to treatment. Nominal variables were described by of proportions with a confidence interval of 95%; Chi-Square test (Pearson's test), based on a significance level of p˂0.05 in all cases.
Measured: will take place over 3 weeks, with one session per week.
Mobility with a goniometer
The range of joint mobility of flexion, extension, inclination and rotation movements will be measured with a goniometer. The outcome measure is in degrees, before and after treatment. Evaluating the comparative effect of percutaneous microelectrolysis with or without current emission in the treatment of cervical pain in trapezius myofascial trigger points.
Measured: will take place over 3 weeks, with one session per week.
Objective pain measurement with a dynamometer
It is the objective measurement of pain, through the measurement of results in the Newton (N) unit to perform force measurements and objectively evaluate the pain threshold at strategic points of the trapezius muscle, using the DINATOR® portable dynamometer. It will be measured with the dynamometer before and after treatment with or without current. Evaluated comparative effect of percutaneous microelectrolysis with or without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius.
Measured: will take place over 3 weeks, with one session per week.
visual analogue scale
The evaluation is carried out through the visual analogue scale (VAS) with the outcome measure from 0 to 10 (10 the worst pain experienced and 0 no pain); change from pain level to baseline pain level before and after treatment. The Chi-Square test (Pearson's test) will be implemented for the analysis of categorical data and the "t" test for paired data for quantitative data, based on a significance level of p˂0.05 in all cases. Evaluated comparative effect of percutaneous microelectrolysis with or without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius.
Measured: will take place over 3 weeks, with one session per week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start16 Aug 2022
- Primary completion30 Nov 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck Pain, PosteriorStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- percutaneous microelectrolysis with or without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius. Both will take place over 3 weeks, with one session per week. The evaluation is carried out through the visual analogue scale (VAS), measurement of force with a dynamometer and mobility with a goniometer. The score will be recorded on a validated neck pain questionnaire (NPQ).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arguello Retamar Verónica Inés, Universidad Nacional de Córdoba
- Investigators
- Vilma Campana, Dr, Study director, Universidad Nacional de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524623
- Sponsor's protocol ID
- 3926
- Status last verified
- Apr 2023
- First submitted
- 13 Aug 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Margalef R, Bosque M, Monclus P, Flores P, Minaya-Munoz F, Valera-Garrido F, Santafe MM. Percutaneous Application of Galvanic Current in Rodents Reverses Signs of Myofascial Trigger Points. Evid Based Complement Alternat Med. 2020 May 28;2020:4173218. doi: 10.1155/2020/4173218. eCollection 2020.
PubMed 32565858
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Percutaneous Microelectrolysis With or Without Current Emission in the Treatment of Cervical Pain in Myofascial Trigger Points of the Trapezius
- ClinicalTrials.gov ID
- NCT05524623
- Acronym / sponsor ID
- 3926
- Conditions
- Neck Pain, Posterior, Myofascial Pain Syndromes
- Keywords
- neck, pain, muscles, needles, Electrolysis, electrotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Universidad Nacional de CórdobaUniversity, hospital or other
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 1 Sep 2022 (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.
Myofascial pain syndrome (MPS) is initial to other pathologies such as neck pain or tension headaches; the symptoms that are located on the area of myofascial trigger points (MTrPs) of specific references in different muscles. MTrPs are palpable, tense bands found in stiff muscle that cause pain and swelling. They affect the disruptive soft tissues, resulting in deterioration of the muscle and fascia; effects that can be transferred further, through the myofascial chain to distant tissues, inducing the referred pain that is the main feature of MPS. MTrPs are treated with stretching, massage, analgesics, acupuncture, dry needling, electrical stimulation, and ultrasound. Percutaneous microelectrolysis (MEP®) is a new technique that uses galvanic current of low intensity and high density. Based on the previous reviews, the investigators consider that the use of MEP in individuals who have MTrPs in the trapezius is more effective than acupuncture treatment. Objectives: To assess the effect of MEP as a technique for treating pain in MTrPs of the trapezius muscle compared to without current emission, analyzing function, pain and strength in MTrPs before and after both treatments.
Detailed description
Myofascial pain syndrome (MPS) is initial to other pathologies such as neck pain or tension headaches; the symptoms that are located on the area of myofascial trigger points (MTrPs) of specific references in different muscles. MTrPs are palpable, tense bands found in stiff muscle that cause pain and swelling. They affect the disruptive soft tissues, resulting in deterioration of the muscle and fascia; effects that can be transferred further, through the myofascial chain to distant tissues, inducing the referred pain that is the main feature of MPS. MTrPs are treated with stretching, massage, analgesics, acupuncture, dry needling, electrical stimulation, and ultrasound. Percutaneous microelectrolysis (MEP®) is a new technique that uses galvanic current of low intensity and high density. Based on the previous reviews, the investigators consider that the use of MEP in individuals who have MTrPs in the trapezius is more effective than acupuncture treatment. Objectives: To assess the effect of MEP as a technique for treating pain in MTrPs of the trapezius muscle compared to without current emission, analyzing function, pain and strength in MTrPs before and after both treatments.
Materials and methods: Randomized controlled clinical research. The study population consists of patients of both sexes between 20 and 60 years of age, with medical referral for neck pain who do not currently receive physiotherapeutic treatment, pain of at least 1 month of evolution, presenting on both sides of the trapezius MTrPs muscle and having signed the informed consent. They will be randomly distributed into: group treated with acupuncture (control) and group treated with MEP. Both will take place over 3 weeks, with one session per week. The evaluation is carried out through the visual analogue scale (VAS), measurement of force with a dynamometer and mobility with a goniometer. The score will be recorded on a validated neck pain questionnaire (NPQ). The Chi-Square test (test) will be implemented for the analysis of categorical data and the \"t\" test for paired data for quantitative data, based on a significance level of p˂0.05 in all cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- percutaneous microelectrolysis with or without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius. Both will take place over 3 weeks, with one session per week. The evaluation is carried out through the visual analogue scale (VAS), measurement of force with a dynamometer and mobility with a goniometer. The score will be recorded on a validated neck pain questionnaire (NPQ).
| Arm | Type | Receives |
|---|---|---|
| without current emission in the treatment | Sham comparator | Other: percutaneous microelectrolysis in myofascial trigger points of the trapeziuspercutaneous microelectrolysis without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius. Both will take place over 3 weeks, with one session per week. |
| wit current emission in the treatment | Active comparator | Other: percutaneous microelectrolysis in myofascial trigger points of the trapeziuspercutaneous microelectrolysis with current emission in the treatment of cervical pain in myofascial trigger points of the trapezius. oth will take place over 3 weeks, with one session per week. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- with medical referral for pain of at least 1 month of evolution
- presenting on both sides of the trapezius MTrPs muscle
Key exclusion criteria (1 listed)
- neck pain who do currently receive physiotherapeutic treatment of at least 1 month of evolution
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 |
|---|---|---|
| percutaneous microelectrolysis in myofascial trigger points of the trapeziusAlso: MEP (percutaneous microelectrolysis), Trigger Pointspercutaneous microelectrolysis with or without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius | Other | wit current emission in the treatment, without current emission in the treatment |
Primary outcome
Northwick Park Neck Pain Questionnaire
Time frame: will take place over 3 weeks, with one session per week.
The validated and adapted Northwick Park Neck Pain Questionnaire (NPQ) relates to activities of daily living. The outcome measure is in Points per NPQ protocol. The questionnaire will be completed prior to treatment. Nominal variables were described by of proportions with a confidence interval of 95%; Chi-Square test (Pearson's test), based on a significance level of p˂0.05 in all cases.
Mobility with a goniometer
Time frame: will take place over 3 weeks, with one session per week.
The range of joint mobility of flexion, extension, inclination and rotation movements will be measured with a goniometer. The outcome measure is in degrees, before and after treatment. Evaluating the comparative effect of percutaneous microelectrolysis with or without current emission in the treatment of cervical pain in trapezius myofascial trigger points.
Objective pain measurement with a dynamometer
Time frame: will take place over 3 weeks, with one session per week.
It is the objective measurement of pain, through the measurement of results in the Newton (N) unit to perform force measurements and objectively evaluate the pain threshold at strategic points of the trapezius muscle, using the DINATOR® portable dynamometer. It will be measured with the dynamometer before and after treatment with or without current. Evaluated comparative effect of percutaneous microelectrolysis with or without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius.
visual analogue scale
Time frame: will take place over 3 weeks, with one session per week.
The evaluation is carried out through the visual analogue scale (VAS) with the outcome measure from 0 to 10 (10 the worst pain experienced and 0 no pain); change from pain level to baseline pain level before and after treatment. The Chi-Square test (Pearson's test) will be implemented for the analysis of categorical data and the "t" test for paired data for quantitative data, based on a significance level of p˂0.05 in all cases. Evaluated comparative effect of percutaneous microelectrolysis with or without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Results publication: PubMed 32565858Margalef R, Bosque M, Monclus P, Flores P, Minaya-Munoz F, Valera-Garrido F, Santafe MM. Percutaneous Application of Galvanic Current in Rodents Reverses Signs of Myofascial Trigger Points. Evid Based Complement Alternat Med. 2020 May 28;2020:4173218. doi: 10.1155/2020/4173218. eCollection 2020.
- Percutaneous Application of Galvanic Current in Rodents Reverses Signs of Myofascial Trigger PointsLink provided by the sponsor.
- 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.
Vilma Campana, Dr study director
Universidad Nacional de Córdoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous microelectrolysis in myofascial trigger points of the trapezius in people with Neck Pain, Posterior and Myofascial Pain Syndromes, run by Universidad Nacional de Córdoba at 1 site in Argentina.
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 2 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: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Northwick Park Neck Pain Questionnaire (time frame: will take place over 3 weeks, with one session per week.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05524623, which also lists 1 linked publication.
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 19 Apr 2023.