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Trial record 46 of 83 for:    PEELING SKIN SYNDROME

Percutaneous Microelectrolysis in the Reduction of Myofascial Trigger Points Pain

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ClinicalTrials.gov Identifier: NCT03636386
Recruitment Status : Active, not recruiting
First Posted : August 17, 2018
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
Universidad Nacional Andres Bello
Information provided by (Responsible Party):
Hernán Andrés de la Barra Ortiz, Quiropraxia y Equilibrio

Brief Summary:
The aim of the design is to investigate the value of percutaneous microelectrolysis (MEP) as an analgesic technique in myofascial trigger points. This research seeks to evaluate the influence of the polar effects of the cathode on the reduction of the threshold of painful pressure and intensity of pain in the myofascial trigger points of the trapezius muscle. An assessment with algometry and visual analog scale will be made in healthy subjects before applying the intervention. The study will evaluate the changes in kilograms per square centimeter of painful pressure threshold and millimeters of pain in a group exposed to the application to percutaneous microelectrolysis (MEP) compared to another group that will not receive the intervention. Both groups will be provided with a basic treatment of therapeutic ultrasound. The treatment will include three sessions with an interval of 3 days. Subsequently, the researchers will proceed to compare the painful pressure threshold and pain intensity obtained from the algometry test and visual analogue scale in each of the groups, and between groups, before and after the procedure. The changes obtained between sessions will be compared.

Condition or disease Intervention/treatment Phase
Myofascial Trigger Point Pain Device: Percutaneous microelectrolysis Device: Ultrasound therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Percutaneous Microelectrolysis in the Reduction of Myofascial Trigger Points Pain: Valuation Through Algometry and Visual Analogue Scale"
Actual Study Start Date : May 23, 2018
Actual Primary Completion Date : December 14, 2018
Estimated Study Completion Date : December 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Percutaneous Microelectrolysis Group
Group exposed to a Direct Current application using an acupuncture needle with intensities in microamps (μA) in the PGm of the upper trapezius muscle. The acupuncture needle will correspond to the negative electrode or cathode.This group will also be treated with conventional Ultrasound (US) on PGm before the application of MEP. The treatment parameters will include; a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes.
Device: Percutaneous microelectrolysis
284/5000 Application of Direct Current through an acupuncture needle with intensities in microamps (μA) in the PGm of the upper trapezius muscle. The acupuncture needle will correspond to the negative electrode or cathode. The intensity of work will be 610μA at the myofascial trigger point.
Other Name: Electrolysis through the polar effect of the cathode

Device: Ultrasound therapy
Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes.
Other Name: Treatment with conventional ultrasound

Active Comparator: Ultrasound therapy
Group treated only with conventional Ultrasound (US) on PGm with a frequency of treatment 1MHz, Intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes.
Device: Ultrasound therapy
Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes.
Other Name: Treatment with conventional ultrasound




Primary Outcome Measures :
  1. Pain Pressure Threshold [ Time Frame: 30 minutes ]
    Pain Intensity expressed in kilograms per square centimeter(kg/cm2) reported by the participants when performing the pressure Algometry test in the sensitive point of the upper trapezius muscle. The Pain Pressure Thereshold will be evaluated through a BASELINE® pressure algometer.


Secondary Outcome Measures :
  1. Pain Intensity [ Time Frame: 30 minutes ]
    Magnitude of pain expressed in millimeters (mm) referred by the participants. The Pain Intensity were evaluated through the Visual Analogue Scale at the moment of performing the pressure Algometry in thesensitive point of the upper trapezius muscle. The analog visual scale that will be used will be of the company GYMNA®.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  1. Inclusion criteria

    • Students of the Faculty of Rehabilitation Sciences.
    • Participants over 18 years old.
    • Participants presenting Hypersensitive Pain Points (Trigger Points) at the level of the trapezius muscle, shortened upper portion. The positive trigger point (+) will be the presence of pain at a pressure of less than 3kg / cm2 at the muscle point of the muscle, or a pressure threshold difference less than 2Kg / cm2 in relation to the same point of the upper trapezius muscle. contralateral
  2. Exclusion criteria

    • Musculoskeletal problems or pathologies of the neck or shoulders in the last 6 months (fractures, sprains, tendinopathies, dislocations, muscle tears, etc.).
    • Participants who present cervical pain.
    • Presence of osteosynthesis materials near shoulders, neck or surrounding areas.
    • Alterations of sensitivity such as hypesthesia, anesthesia or hyperesthesia in the neck, shoulders and / or arms.
    • Presence of wounds or skin alterations in the shoulder region (psoriasis, scars, keloids).
    • Apprehension or fear of the application of electrotherapy.
    • Ingestion of medications or analgesic pharmacological treatment at the time of recruitment (Non-steroidal anti-inflammatory or steroidal).
  3. Elimination Criteria

    • Non-tolerance of the intervention with electrotherapy that requires the suspension of treatment.
    • Non-completion of the evaluation protocol (Attendance at all scheduled sessions).

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): NCT03636386


Locations
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Chile
Universidad Andrés Bello
Santiago de Chile, Comuna Las Condes, Chile, 7550000
Sponsors and Collaborators
Quiropraxia y Equilibrio
Universidad Nacional Andres Bello
Investigators
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Principal Investigator: Hernán A de la Barra Ortiz, Mg. Universidad Andrés Bello

Additional Information:
Publications:

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Responsible Party: Hernán Andrés de la Barra Ortiz, Clinical Professor, Quiropraxia y Equilibrio
ClinicalTrials.gov Identifier: NCT03636386     History of Changes
Other Study ID Numbers: 60312069
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hernán Andrés de la Barra Ortiz, Quiropraxia y Equilibrio:
Electrotherapy
Electrolysis
Myofascial Pain Syndromes
Pain Threshold
Visual Analog Pain Scale

Additional relevant MeSH terms:
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Pain
Myofascial Pain Syndromes
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases