"Effectiveness of Percutaneous Electrical Nerve Stimulation on the Sciatic Nerve in Patients Undergoing Surgical Reconstruction of the Anterior Cruciate Ligament. A Randomized Clinical Trial".
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Maximal Isometric Strength of the Hamstring Musculature
研究概览
简要总结
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.
详细描述
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.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Chronic or rheumatic joint disease
- •Central nervous system disorder
- •Heart disease (pacemaker)
- •Neoplasms
- •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
研究组 & 干预措施
Control Group
Experimental Group
干预措施: Experimental Group (Procedure)
结局指标
主要结局
Maximal Isometric Strength of the Hamstring Musculature
时间窗: 5 weeks after surgery
Maximal Isometric Strength of the Hamstring Musculature This was recorded with the patient in a prone position, with the knee flexed at 90 degrees and the ankle in plantar flexion. The patient was instructed to perform an isometric knee flexion against a Lafayette hand-held dynamometer, positioned at the level of the Achilles tendon. Three repetitions were recorded and measured in Newtons, with a 60-second rest interval between repetitions.
次要结局
- Surface Electromyography of the Hamstring Musculature(5 weeks after surgery)
- Postsurgery Pain(5 weeks after surgery)
- Thigh Circumference Measurement(5 weeks after surgery)
- Intra-Articular Effusion(5 weeks after surgery)
- Knee Range of Motion(5 weeks after surgery)
研究者
Javier Reina Abellan; PhD
Clinical Professor
Universidad de Murcia