Clinical trial NCT06713200: Effectiveness Of The Application Of Percutaneous Electrolysis On Muscular Scar Tissue.
Official title: Effectiveness Of The Application Of Percutaneous Electrolysis On Muscular Scar Tissue Of The Medial Gastrocnemius: A Doble-Blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Muscle Injury
Fibrosis
Keywords: TENNIS LEG
GASTROCNEMIOUS INJURY
FIBROSIS
PERCUTANEOUS ELECTROLYSIS
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will include pacients randomized into three treatment groups: high-intensity percutaneous electrolysis, low-intensity and a control group with sham treatment.
Primary purpose: TREATMENT

Brief summary: OBJECTIVE: Determine the effectiveness of an intervention that consists of the application of percutaneous electrolysis in different doses compared to the application of a simulated intervention in adults who present a muscle tear in the internal gastrocnemius.

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.


Eligibility criteria: Inclusion Criteria:

* Muscle injury in the medial gastrocnemius
* 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:

* Active rehabilitation for another musculoskeletal pathology.
* Belenophobia
* Immunosuppression.
* Uncontrolled metabolic diseases.

Primary outcomes:
measure: Pain at rest
timeFrame: From admission to the end of treatment at 28 days
measure: Pain on load
timeFrame: From admission to the end of treatment at 28 days
measure: Level of kinesiophobia
timeFrame: From admission to the end of treatment at 28 days
measure: Ankle dorsiflexion range with the knee in extension.
timeFrame: From admission to the end of treatment at 28 days
measure: Muscle fatigue
timeFrame: From admission to the end of treatment at 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Universidad de Salamanca
Study officials:
affiliation: University of Salamanca
name: Fausto Barbero-Iglesias, Doctor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.