Immediate Effects of Neuromuscular Electrical Stimulation on Pain and Function in Achilles Tendon Disorders

Официальное название

Immediate Effects of Neuromuscular Electrical Stimulation on Pain and Functional Performance in Individuals With Achilles Tendinopathy and Tendon Rupture: A Randomized Crossover Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Neuromuscular Electrical Stimulation (NMES)
  Neuromuscular electrical stimulation-induced contractions will be delivered using an electrical stimulator connected to a pair of 5×5 cm self-adhesive surface electrodes. Stimulation will be applied in a superimposed manner during voluntary movement, at a frequency of 75 Hz and a phase duration of 400 µs.

Первичные конечные точки

• Pain level [Срок оценки: Immediately after the performance of the functional task]

Вторичные конечные точки (12)

• Total time [Срок оценки: Immediately after the performance of the functional task.]
• Maximal displacement [Срок оценки: Immediately after the performance of the functional task.]
• Total work [Срок оценки: Immediately after the performance of the functional task.]
• Total power [Срок оценки: Immediately after the performance of the functional task.]
• Number of repetitions [Срок оценки: Immediately after the performance of the functional task.]
• Peripheral oxygen extraction [Срок оценки: Immediately after the performance of the functional task.]
• Maximal Achilles tendon displacement [Срок оценки: Immediately after the performance of the functional task.]
• Lenght of achilles tendon [Срок оценки: Baseline (prior to Block A only)]
• Thickness of achilles tendon [Срок оценки: Baseline (prior to Block A only)]
• Cross-sectional area of achilles tendon [Срок оценки: Baseline (prior to Block A only)]
• Presence of neovascularization of the Achilles tendon [Срок оценки: Baseline (prior to Block A only)]
• Elastic modulus [Срок оценки: Baseline (prior to Block A only)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• University of Brasilia — Brasília

Идентификаторы

NCT: NCT07453485 · CAAE: 94397825.9.0000.8093

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗