Immediate Effects of Neuromuscular Electrical Stimulation on Pain and Function in Achilles Tendon Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Brasilia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Neuromuscular Electrical Stimulation (NMES)
DeviceNeuromuscular 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.
Treatment groups
30 Participants
are divided into 4 treatment groupsGroup A: Control without active interventionNo intervention 0 interventions
Group B: Electrical stimulation applied at the maximum tolerated intensityExperimental treatment 1 intervention
Group C: Control with sham stimulationPlacebo comparator 1 intervention
Group D: Sensory-level electrical stimulationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain level
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.
Time frame
Immediately after the performance of the functional taskSecondary outcomes
1
Total time
The total time (s) during the single-leg heel rise task will be measured using the MuscleLab® system.
Time frame
Immediately after the performance of the functional task.2
Maximal displacement
The maximal displacement (cm) during the single-leg heel rise task will be measured using the MuscleLab® system.
Time frame
Immediately after the performance of the functional task.3
Total work
The total work (J) during the single-leg heel rise task will be measured using the MuscleLab® system.
Time frame
Immediately after the performance of the functional task.4
Total power
The total power (W) during the single-leg heel rise task will be measured using the MuscleLab® system.
Time frame
Immediately after the performance of the functional task.Sponsors and contacts
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Source ClinicalTrials.gov