Effectiveness Of The Application Of Percutaneous Electrolysis On Muscular Scar Tissue.

Not Applicable

Active, not recruiting

• Conditions: Muscle Injury; Fibrosis

• Registration Number: NCT06713200
• Lead Sponsor: University of Salamanca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-03
• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Primary Completion: 2024-12
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain at rest	From admission to the end of treatment at 28 days	Pain assessment of participants' pain in both upright and contracted positions will be performed using a 10-point Verbal Numerical Pain Scale (0=no pain, 10=maximum pain tolerable). Subjects will be asked to rate numerically the pain at rest and in a maintained position of elevation of both heels, also commonly known as "standing on tiptoe". In the latter position, 10 will be considered if the subjects fail to stand in this position for at least one complete elevation.
Pain on load	From admission to the end of treatment at 28 days	Pain assessment of participants' pain in both upright and contracted positions will be performed using a 10-point Verbal Numerical Pain Scale (0=no pain, 10=maximum pain tolerable). Subjects will be asked to rate numerically the pain at rest and in a maintained position of elevation of both heels, also commonly known as "standing on tiptoe". In the latter position, 10 will be considered if the subjects fail to stand in this position for at least one complete elevation.
Level of kinesiophobia	From admission to the end of treatment at 28 days	Recovery from painful injuries is associated with fear of movement or also called kinesiophobia. It could be defined as an irrational or excessive fear of movement for fear of injury or re-injury. That is why a kinesiophobia questionnaire (Annex II) will be provided at the beginning of the study (day I, assessment and first intervention) to all participants to assess kinesiophobia to perform certain movements that may cause pain or worsen previous injuries. It consists of 11 questions with a minimum score of 11 and a maximum score of 44.
Ankle dorsiflexion range with the knee in extension.	From admission to the end of treatment at 28 days	The evaluation of this variable will be carried out by measuring the angle extracted from the dorsiflexion of the ankle with a knee extension. This stretch is commonly performed in sports practice so patients are generally already familiar with it. The stretches will be performed with the participants barefoot. Likewise, the participants will be instructed on the positioning of the test. The leg to be evaluated will be placed in such a way that the foot is placed in the midline of an area marked on the floor, and the foot of the healthy leg will be placed forward at the distance of one step. The end point of the gastrocnemius stretch will be defined as the point at which the participants feel discomfort without lifting the heel and without pelvic rotation.
Muscle fatigue	From admission to the end of treatment at 28 days	Fatigue in this muscle group will be assessed by performing a heel-raise test at the beginning and end of the trial for all participants who have completed it. The test consists of placing the patient on one leg and, using a metronome at a speed of 40 beats per minute (Garmin Fénix 5/5S), asking them to raise their heels. If they are unable to raise their heels for 3 consecutive beats, fatigue will be considered. Light support on a wall is allowed to maintain the patient's balance.

Trial Locations

Locations (1)

Universidad de Salamanca; 🇪🇸 Salamanca, Spain