NCT04334772

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

8 days

First QC Date

April 2, 2020

Last Update Submit

April 18, 2022

Conditions

Keywords

Electric Stimulation TherapyElectrolysisMuscle Stretching ExercisesMuscle StrengthAgilityHamstring Muscles

Outcome Measures

Primary Outcomes (3)

  • Maximum isometric strength differences

    Comparing maximum hamstring isometric strength changes pre and post application of microelectrolysis and hamstring stretching protocol.

    Baseline and 2 hours later (1 session of treatment)

  • Joint Range differences

    Comparing maximum knee extention range pre and post application of microelectrolysis and hamstring stretching protocol.

    Baseline and 2 hours later (1 session of treatment)

  • Agility differences

    Comparison of time changes in performing the T agility test pre and post application of microelectrolysis and hamstring stretching protocol.

    Baseline and 2 hours later (1 session of treatment)

Study Arms (3)

Muscle belly Microelectrolysis

EXPERIMENTAL

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 MicroelectrolysisOther: Stretching exercises

Tendon Microelectrolysis

EXPERIMENTAL

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 MicroelectrolysisOther: Stretching exercises

Control

ACTIVE COMPARATOR

Group to receive treatment by assisted passive stretching performed by a physical therapist on tightness hamstrings.

Other: Stretching exercises

Interventions

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.

Muscle belly Microelectrolysis

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

Tendon Microelectrolysis

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

ControlMuscle belly MicroelectrolysisTendon Microelectrolysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Andrés Bello

Santiago, Las Condes, 7591538, Chile

Location

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MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • HernĂ¡n A de la Barra, Msc

    Universidad Andrés Bello

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2020

First Posted

April 6, 2020

Study Start

October 1, 2020

Primary Completion

October 9, 2020

Study Completion

January 31, 2021

Last Updated

April 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations