Immediate Effects of Neuromuscular Electrical Stimulation on Pain and Function in Achilles Tendon Disorders
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neuromuscular Electrical Stimulation (NMES).
- Who it may be relevant to
- Registry conditions: Achilles Tendinopathy (AT), Achilles Tendon Rupture. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Immediate Effects of Neuromuscular Electrical Stimulation on Pain and Functional Performance in Individuals With Achilles Tendinopathy and Tendon Rupture: A Randomized Crossover Clinical Trial
Overview
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.
Detailed description
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.
Interventions
- Device 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.
Primary outcome measures
- Pain level [Time frame: Immediately after the performance of the functional task]
Secondary outcome measures (12)
- Total time [Time frame: Immediately after the performance of the functional task.]
- Maximal displacement [Time frame: Immediately after the performance of the functional task.]
- Total work [Time frame: Immediately after the performance of the functional task.]
- Total power [Time frame: Immediately after the performance of the functional task.]
- Number of repetitions [Time frame: Immediately after the performance of the functional task.]
- Peripheral oxygen extraction [Time frame: Immediately after the performance of the functional task.]
- Maximal Achilles tendon displacement [Time frame: Immediately after the performance of the functional task.]
- Lenght of achilles tendon [Time frame: Baseline (prior to Block A only)]
- Thickness of achilles tendon [Time frame: Baseline (prior to Block A only)]
- Cross-sectional area of achilles tendon [Time frame: Baseline (prior to Block A only)]
- Presence of neovascularization of the Achilles tendon [Time frame: Baseline (prior to Block A only)]
- Elastic modulus [Time frame: Baseline (prior to Block A only)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- University of Brasilia — Brasília
Identifiers
NCT: NCT07453485 · CAAE: 94397825.9.0000.8093