Immediate Effects of Neuromuscular Electrical Stimulation on Pain and Functional Performance in Individuals With Achilles Tendinopathy and Tendon Rupture: A Randomized Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain level
研究概览
简要总结
The Achilles tendon exhibits high tensile strength and can withstand extremely high loads. However, it is susceptible to injuries such as tendinopathies and ruptures, which are associated with structural alterations and loss of function. Strategies have been investigated to enhance clinical rehabilitation. Nevertheless, the effects of neuromuscular electrical stimulation on pain and functional improvement, as well as the optimal dosing parameters for the rehabilitation of Achilles tendon injuries, remain inconclusive. The aim of this study is to compare the immediate effects of two electrical stimulation protocols on pain, functional performance, peripheral oxygen extraction, and maximal tendon displacement during a single leg heel rise functional task in patients with Achilles tendinopathy and/or a history of Achilles tendon rupture. In addition, this study aims to characterize Achilles tendon structural properties and ankle plantarflexor muscle strength in this population.
详细描述
All groups will be composed of participants with a primary complaint of pain and/or a history of previous Achilles tendon rupture. Participants will perform the interventions in two blocks separated by a seven-day interval (wash-out). Block A: (1) control without active intervention and (2) electrical stimulation applied at the maximum tolerated intensity. Block B: (3) control with sham stimulation and (4) sensory-level electrical stimulation. Block A will always be performed first, followed by Block B. Interventions within each block will be conducted in three sets of 10 repetitions, totaling six sets per day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Primary complaint of pain localized in the midportion (2-6 cm proximal to the calcaneus) or insertion of the Achilles tendon, and/or a history of Achilles tendon rupture occurring at least 3 months prior to assessment.
- •Pain on palpation of the Achilles tendon.
- •Pain during load-bearing activities
排除标准
- •Exclusive diagnosis of bursitis confirmed by ultrasonographic assessment
- •Any other lower limb injury
- •History of lower limb surgery within the past year
- •Previous Achilles tendon tenoplasty performed less than 3 months prior to assessment
研究组 & 干预措施
Control without active intervention
In this group, participants will perform three sets of 10 repetitions of the single leg heel rise functional task without the application of electrical stimulation. Immediately after each set, pain level, functional performance, peripheral oxygen extraction, and maximal Achilles tendon displacement will be assessed.
Electrical stimulation applied at the maximum tolerated intensity
Under this condition, participants will perform three sets of 10 repetitions of the single leg heel rise functional task with superimposed electrical stimulation applied at the maximum tolerated intensity, characterized by visible muscle contraction and associated with a self-reported discomfort level between 8 and 10 on the Numeric Rating Scale. Immediately after each set, pain level, functional performance, peripheral oxygen extraction, and maximal Achilles tendon displacement will be assessed.
干预措施: Neuromuscular Electrical Stimulation (NMES) (Device)
Control with sham stimulation
For this condition, participants will perform three sets of 10 repetitions of the single leg heel rise functional task with superimposed sham electrical stimulation. Electrical stimulation parameters will initially be configured identically to those used in the active intervention. However, to ensure adequate blinding, stimulation will be applied for approximately 40 seconds and then gradually reduced until complete cessation. From this point onward, no additional current will be delivered, although the device will remain on and the electrodes will remain in place throughout the test. Immediately after each set, pain level, functional performance, peripheral oxygen extraction, and maximal Achilles tendon displacement will be assessed.
干预措施: Neuromuscular Electrical Stimulation (NMES) (Device)
Sensory-level electrical stimulation
In this condition, participants will perform three sets of 10 repetitions of the single leg heel rise functional task with superimposed electrical stimulation applied at the sensory level, defined as the highest intensity that does not elicit visible muscle contraction. Immediately after each set, pain level, functional performance, peripheral oxygen extraction, and maximal Achilles tendon displacement will be assessed.
干预措施: Neuromuscular Electrical Stimulation (NMES) (Device)
结局指标
主要结局
Pain level
时间窗: Immediately after the performance of the functional task
Pain intensity during the single leg heel rise task will be assessed using the Visual Analog Scale, consisting of a numerical scale ranging from 0 to 10 points, in which 0 represents no pain and 10 corresponds to the worst pain ever experienced by the participant.
次要结局
- Total time(Immediately after the performance of the functional task.)
- Maximal displacement(Immediately after the performance of the functional task.)
- Total work(Immediately after the performance of the functional task.)
- Total power(Immediately after the performance of the functional task.)
- Number of repetitions(Immediately after the performance of the functional task.)
- Peripheral oxygen extraction(Immediately after the performance of the functional task.)
- Maximal Achilles tendon displacement(Immediately after the performance of the functional task.)
- Lenght of achilles tendon(Baseline (prior to Block A only))
- Thickness of achilles tendon(Baseline (prior to Block A only))
- Cross-sectional area of achilles tendon(Baseline (prior to Block A only))
- Presence of neovascularization of the Achilles tendon(Baseline (prior to Block A only))
- Elastic modulus(Baseline (prior to Block A only))
- Shear wave velocity(Baseline (prior to Block A only))
- Depth(Baseline (prior to Block A only))
- Isometric strength(Baseline (prior to Block A only))