Effectiveness Of The Application Of Percutaneous Electrolysis On Muscular Scar Tissue.
NCT ID: NCT06713200
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2024-07-03
2025-01-31
Brief Summary
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MATERIAL AND METHODS: Around fifty adults with muscle tears in the medial gastrocnemius will be included in the following study. The first group will be treated with high-intensity percutaneous electrolysis (3 mA), the second group will be treated with low-intensity percutaneous electrolysis (0.3 mA), and the third group will receive a sham intervention. Myofascial pain, level of kinesiophobia, range of ankle dorsiflexion with full knee extension, and triceps surae muscle fatigue will be evaluated both before and after treatment.
APPLICABILITY OF THE EXPECTED RESULTS: The results of this study are intended to help provide information about the effects of electrolysis on muscle tears, thus improving their management. Likewise, this work can contribute to the knowledge of the use of percutaneous electrolysis since it applies two protocols with different intensity and application time. In this way, it will provide information on the treatment, management and prognosis of muscle injuries addressed through invasive physiotherapy and more specifically, percutaneous electrolysis.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Subjects treated with high-intensity percutaneous electrolysis.
High intensity percutaneous electrolysis
A sterile, disposable stainless steel needle of different lengths depending on the area to be treated will be connected to the EP device; the gauge of these needles will be 0.25 mm. A current of 3 mA will be applied for 3 times with a duration of 3 seconds each. In order to avoid biases, the technique will be performed for 90 seconds as in the low intensity treatment group and in the last 20 seconds the current will be applied with the parameters previously described. Three sessions divided in three consecutive weeks will be applied.
Subjects treated with low intensity percutaneous electrolysis.
Low intensity Percutaneous Electrolysis
This technique will be performed with the same instrument as the high intensity technique. It differs from the previous treatment group in that the current intensity in this case will be of an amperage of 0.3mA during 90 seconds. In the same way, 3 sessions divided in 21 consecutive days will be applied.
Subjects treated with simulated percutaneous electrolysis
Simulated Percutaneous Electrolysis
The needle and PD device will be connected in the same way as for the other treatment groups. The needle will be inserted without reaching the lesion area and the characteristic sound of turning on the PD machine will be made. It will last 90 seconds and at no time the galvanic current will be applied. The same aseptic precautions will be applied, in addition to performing the same final hemostasis guidelines and providing the same post-treatment guidelines as for all the other subjects in the study.
Interventions
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High intensity percutaneous electrolysis
A sterile, disposable stainless steel needle of different lengths depending on the area to be treated will be connected to the EP device; the gauge of these needles will be 0.25 mm. A current of 3 mA will be applied for 3 times with a duration of 3 seconds each. In order to avoid biases, the technique will be performed for 90 seconds as in the low intensity treatment group and in the last 20 seconds the current will be applied with the parameters previously described. Three sessions divided in three consecutive weeks will be applied.
Low intensity Percutaneous Electrolysis
This technique will be performed with the same instrument as the high intensity technique. It differs from the previous treatment group in that the current intensity in this case will be of an amperage of 0.3mA during 90 seconds. In the same way, 3 sessions divided in 21 consecutive days will be applied.
Simulated Percutaneous Electrolysis
The needle and PD device will be connected in the same way as for the other treatment groups. The needle will be inserted without reaching the lesion area and the characteristic sound of turning on the PD machine will be made. It will last 90 seconds and at no time the galvanic current will be applied. The same aseptic precautions will be applied, in addition to performing the same final hemostasis guidelines and providing the same post-treatment guidelines as for all the other subjects in the study.
Eligibility Criteria
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Inclusion Criteria
* Pain in the area of injury
* Informed of the purpose, risks and benefits of this study and written consent to participate in the trial.
* Available for follow-up.
Exclusion Criteria
* Belenophobia
* Immunosuppression.
* Uncontrolled metabolic diseases.
18 Years
65 Years
ALL
No
Sponsors
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University of Salamanca
OTHER
Responsible Party
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Carlos Vicente Vega
Graduated in physiotherapy
Principal Investigators
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Fausto Barbero-Iglesias, Doctor
Role: STUDY_DIRECTOR
University of Salamanca
Locations
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Universidad de Salamanca
Salamanca, , Spain
Countries
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References
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De-la-Cruz-Torres B, Romero-Rodriguez B, Romero-Morales C. Ultrasound-Guided Percutaneous Needle Electrolysis Combined With Therapeutic Exercise May Add Benefit in the Management of Soleus Injury in Female Soccer Players: A Pilot Study. J Sport Rehabil. 2022 Nov 21;32(3):265-271. doi: 10.1123/jsr.2022-0021. Print 2023 Mar 1.
Lopez-Martos R, Gonzalez-Perez LM, Ruiz-Canela-Mendez P, Urresti-Lopez FJ, Gutierrez-Perez JL, Infante-Cossio P. Randomized, double-blind study comparing percutaneous electrolysis and dry needling for the management of temporomandibular myofascial pain. Med Oral Patol Oral Cir Bucal. 2018 Jul 1;23(4):e454-e462. doi: 10.4317/medoral.22488.
De-la-Cruz-Torres B, Barrera-Garcia-Martin I, Valera-Garrido F, Minaya-Munoz F, Romero-Morales C. Ultrasound-Guided Percutaneous Needle Electrolysis in Dancers with Chronic Soleus Injury: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2020 Aug 27;2020:4156258. doi: 10.1155/2020/4156258. eCollection 2020.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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PI 2023 08 1418 - TD
Identifier Type: -
Identifier Source: org_study_id