Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Percutaneous Microelectrolysis in Agility, Joint Range and Strength (MEP)

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.
 
ClinicalTrials.gov Identifier: NCT04334772
Recruitment Status : Not yet recruiting
First Posted : April 6, 2020
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Quiropraxia y Equilibrio

Brief Summary:

Electrical stimulation has a wide range of clinical applications in rehabilitation, being used for activities such as strengthening, pain control, management of edema, or control of inflammation after injury or surgery. One of the most classic forms of electrotherapy is direct current (DC), which stands out for its particular effects and which are not achieved with other forms of electrical stimulation.

A new therapeutic alternative through DC is Percutaneous Microelectrolysis (MEP), which began to have a significant boom in Latin America a couple of years ago. MEP is a minimally invasive procedure in which a low intensity DC is used. MEP has been proposed as a therapeutic resource to reduce muscle contractions and shortenings, thus favoring flexibility, although research to support this effect is lacking.

Muscle flexibility is an important component in rehabilitation and training programs. In lower limbs, tightness hamstring muscles is a common condition that limits flexibility and affects sedentary and athletic people. Loss of flexibility of hamstrings has been reported for different sports disciplines, showing a decrease in a high percentage with the exception of sports such as rhythmic gymnastics and dance where flexibility is essential for good performance. Loss of hamstring extensibility has been associated with a higher incidence of muscle tears, patellar tendinopathy, low back pain and alterations in lumbopelvic rhythm associated with compensatory biomechanical changes such as limb shortening, pelvic retroversion, and increased thoracic kyphosis, among others.

It is interesting to investigate the effectiveness of MEP in hamstring tightness. A increase in hamstring flexibility can contribute to increased joint range, muscle strength, and lower limb agility.


Condition or disease Intervention/treatment Phase
Hamstring Contractures Device: Muscle belly Microelectrolysis Device: Tendon Microelectrolysis Other: Stretching exercises Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Percutaneous Microelectrolysis and Stretching Exercises on Agility, Strength, and Knee Joint Range in Hamstring Tightness in Athletes
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 9, 2020
Estimated Study Completion Date : January 31, 2021

Arm Intervention/treatment
Experimental: Muscle belly Microelectrolysis

Group to receive direct current application percutaneously using an acupuncture needle with intensities in microamps (µA) at hamstring muscular belly. The acupuncture needle will correspond to the negative electrode or cathode.

The group will also receive a passive stretching exercise treatment by a physical therapist.

Device: Muscle belly Microelectrolysis
three applications of direct current at 600 µA interrupted by intervals of 30 seconds between application at the level of the muscular belly of the shortened hamstrings.

Other: Stretching exercises
5 sets of passive static hamstring stretches using the straight leg extension (SLR) test for a time of 30 seconds and interval of 30 seconds for each

Experimental: Tendon Microelectrolysis

Group to receive direct current application percutaneously using an acupuncture needle with intensities in microamps (µA) at the hamstring tendon. The acupuncture needle will correspond to the negative electrode or cathode.

The group will also receive a passive stretching exercise treatment by a physical therapist.

Device: Tendon Microelectrolysis
three applications of direct current at 600 µA interrupted by intervals of 30 seconds between application in the tendon of the shortened hamstrings.

Other: Stretching exercises
5 sets of passive static hamstring stretches using the straight leg extension (SLR) test for a time of 30 seconds and interval of 30 seconds for each

Active Comparator: Control
Group to receive treatment by assisted passive stretching performed by a physical therapist on tightness hamstrings.
Other: Stretching exercises
5 sets of passive static hamstring stretches using the straight leg extension (SLR) test for a time of 30 seconds and interval of 30 seconds for each




Primary Outcome Measures :
  1. Maximum isometric strength differences [ Time Frame: Baseline and 2 hours later (1 session of treatment) ]
    Comparing maximum hamstring isometric strength changes pre and post application of microelectrolysis and hamstring stretching protocol.

  2. Joint Range differences [ Time Frame: Baseline and 2 hours later (1 session of treatment) ]
    Comparing maximum knee extention range pre and post application of microelectrolysis and hamstring stretching protocol.

  3. Agility differences [ Time Frame: Baseline and 2 hours later (1 session of treatment) ]
    Comparison of time changes in performing the T agility test pre and post application of microelectrolysis and hamstring stretching protocol.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants over 18 years of age.
  • Athletes from the university teams in the branches of rugby, soccer, basketball or tennis.
  • Presence of hamstring shortening in one of the two extremities (positive straight leg elevation test or Straight Leg Raising). It will be considered as a positive test when the participant, in the supine position, shows tension or discomfort in the posterior region of the thigh when passively raising the lower limb for any angle less than 80 ° of hip flexion with extended knee. In the event that the participant presents a bilateral shortening, the limb with the lower elevation will be taken as shortened hamstrings.

Exclusion criteria.

  • Pain when performing hip or knee movements.
  • Musculoskeletal injuries such as fractures, sprains, tears, dislocations, contusions, or joint problems of the lower extremities in the past 3 months.
  • Skin disorders such as scars, burns, psoriasis or wounds in the posterior region of the thighs.
  • Neurological signs or symptoms such as tingling, loss of sensation in the lower extremities (partial or complete), weakness, changes in color or temperature in the thigh, legs or foot.
  • Background or circulatory abnormalities in the lower extremities such as arterial ischemia, venous insufficiency, embolism, post-phlebitic syndrome, lymphedema or deep vein thrombosis.
  • Joint hypermobility (positive Beighton hypermobility test).
  • Intake of medications or anti-inflammatory drug treatment at the time of recruitment (includes non-steroidal or steroidal anti-inflammatory drugs).
  • Allergy to metals.
  • Apprehension or fear of the application of electric current.
  • Belonephobia (extreme and uncontrollable fear of needles and other objects that can cause bloody wounds such as pins, knives, pocket knives, syringes, etc.).

Elimination criteria.

  • Discomfort during the intervention with electrotherapy that requires stopping treatment.
  • Failure to complete the evaluation protocol (attendance at all scheduled evaluation 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): NCT04334772


Contacts
Layout table for location contacts
Contact: Hernán A de la Barra, Msc 26618402 ext +56 hdelabarra@unab.cl
Contact: Jaime A Opazo, Msc 26618402 ext +56 quiropraxiayequilibrio@gmail.com

Locations
Layout table for location information
Chile
Universidad Andrés Bello
Santiago de Chile, Las Condes, Chile, 7591538
Contact: Jaime Opazo, Mg.    562226618402    quiropraxiayequilibrio@gmail.com   
Contact: Hernán Andrés HB de la Barra Ortiz, Mg.    562226618402    quiropraxiayequilibrio@gmail.com   
Principal Investigator: Hernán A de la Barra Ortiz, Mg.         
Sub-Investigator: Jaime A Opazo, Mg.         
Sub-Investigator: Sebastián A Acevedo Cangas, Lic         
Sub-Investigator: Sebastián A Velásquez Velásquez, Lic.         
Sub-Investigator: Antonio I Cumio Herrera, Lic         
Sub-Investigator: Felipe I Oñate García, Lic         
Sponsors and Collaborators
Quiropraxia y Equilibrio
Investigators
Layout table for investigator information
Principal Investigator: Hernán A de la Barra, Msc Universidad Andrés Bello
Publications:

Layout table for additonal information
Responsible Party: Quiropraxia y Equilibrio
ClinicalTrials.gov Identifier: NCT04334772    
Other Study ID Numbers: 603042020
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Quiropraxia y Equilibrio:
Electric Stimulation Therapy
Electrolysis
Muscle Stretching Exercises
Muscle Strength
Agility
Hamstring Muscles
Additional relevant MeSH terms:
Layout table for MeSH terms
Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases