Effectiveness of Percutaneous Electrolysis in Subacute and Early Chronic Medial Gastrocnemius Muscle Injuries: A Single-Blinded Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Pain at rest
研究概览
简要总结
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.
详细描述
Before the application of percutaneous electrolysis (or sham procedure), all participants underwent a standardized pre-treatment protocol including massage therapy, joint mobilization, and radiofrequency diathermy. This protocol was applied uniformly across all groups to ensure consistency and replicate routine clinical practice conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Active rehabilitation for another musculoskeletal pathology.
- •Belenophobia
- •Immunosuppression.
- •Uncontrolled metabolic diseases.
研究组 & 干预措施
Subjects treated with high-intensity percutaneous electrolysis.
All participants received a standardized pre-treatment protocol consisting of 10 minutes of massage therapy to the triceps surae, 5 minutes of subtalar joint mobilization, and 10 minutes of radiofrequency diathermy (0.5 MHz, capacitive mode) prior to needle insertion.
干预措施: High intensity percutaneous electrolysis (Procedure)
Subjects treated with low intensity percutaneous electrolysis.
All participants received a standardized pre-treatment protocol consisting of 10 minutes of massage therapy to the triceps surae, 5 minutes of subtalar joint mobilization, and 10 minutes of radiofrequency diathermy (0.5 MHz, capacitive mode) prior to needle insertion.
干预措施: Low intensity Percutaneous Electrolysis (Procedure)
Subjects treated with simulated percutaneous electrolysis
All participants received a standardized pre-treatment protocol consisting of 10 minutes of massage therapy to the triceps surae, 5 minutes of subtalar joint mobilization, and 10 minutes of radiofrequency diathermy (0.5 MHz, capacitive mode) prior to needle insertion.
干预措施: Simulated Percutaneous Electrolysis (Procedure)
结局指标
主要结局
Pain at rest
时间窗: 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
时间窗: 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
时间窗: 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.
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Carlos Vicente Vega
Graduated in physiotherapy
University of Salamanca