Effectiveness of Stimulation on the Sciatic Nerve in ACLR

Официальное название

"Effectiveness of Percutaneous Electrical Nerve Stimulation on the Sciatic Nerve in Patients Undergoing Surgical Reconstruction of the Anterior Cruciate Ligament. A Randomized Clinical Trial".

Обзор

After randomization, the control group will receive conventional physiotherapy, including manual therapy and therapeutic exercise for ACL rehabilitation. The first experimental group will undergo percutaneous electrical nerve stimulation of the sciatic nerve, while the second experimental group will receive a placebo stimulation. Both interventions aim to improve isometric strength, muscle activation, joint range of motion, and thigh circumference, as well as reduce pain and intra-articular effusion. The procedure involves needle insertion into the sciatic nerve epineurium, placement of a surface electrode on the hamstrings, and connection to an electrostimulator.

Подробное описание

After randomization, participants in the control group will undergo only the conventional physiotherapy program, which consists of manual therapy and therapeutic exercise for the rehabilitation of the anterior cruciate ligament. The first experimental group will receive a percutaneous electrical nerve stimulation protocol applied to the sciatic nerve, consisting of 10 cycles of 10 seconds of electrical current followed by 10 seconds of rest, with the intensity adjusted to the patient's tolerance threshold. The second experimental group will follow the same procedure but with a placebo stimulation. The interventions aim to improve isometric strength, muscle activation, joint range of motion, and thigh circumference, while also reducing pain and intra-articular effusion. The experimental procedure involves inserting a needle into the epineurium of the sciatic nerve after disinfecting the area and placing a surface electrode on the hamstring muscles, followed by connecting the needle to an electrostimulator.

Вмешательства

• Процедура Experimental Group
  Percutaneous Electrical Nerve Stimulation on the Sciatic Nerve

Первичные конечные точки

• Maximal Isometric Strength of the Hamstring Musculature [Срок оценки: 5 weeks after surgery]

Вторичные конечные точки (5)

• Surface Electromyography of the Hamstring Musculature [Срок оценки: 5 weeks after surgery]
• Postsurgery Pain [Срок оценки: 5 weeks after surgery]
• Thigh Circumference Measurement [Срок оценки: 5 weeks after surgery]
• Intra-Articular Effusion [Срок оценки: 5 weeks after surgery]
• Knee Range of Motion [Срок оценки: 5 weeks after surgery]

Критерии участия

Критерии включения

• Use of the Semitendinous and Gracilis tendons for ACL Reconstruction
• Joint Range of Motion greater than or equal to 90
• Primary ACL injury in the leg to be treated

Критерии исключения

• Chronic or rheumatic joint disease
• Central nervous system disorder
• Heart disease (pacemaker)
• Neoplasms
• Epilepsy
• Coagulopathies (use of anticoagulants)
• History of spinal surgery or lumbar disease
• History of neurological disorders
• Prosthesis or osteosynthesis in the operated leg
• Structural discrepancy in lower-limb length
• Belonephobia (overwhelming fear of needles)
• Neuropathic pain or bilateral symptoms
• Use of analgesics
• Quadriceps tendon graft harvest
• Body mass index <20 or >30 kg/m²
• Acute muscle injuries
• Knee joint instability
• Acute joint inflammation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Clinica CEMTRO, Montecarmelo, Madrid — Madrid

Идентификаторы

NCT: NCT07569796 · CE102505

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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