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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07453485
Enrollment
30
Registered
2026-03-06
Start date
2026-01-06
Completion date
2029-12-30
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles Tendinopathy (AT), Achilles Tendon Rupture

Keywords

Achilles tendon, Achilles tendinopathy, Achilles tendon rupture, Neuromuscular electrical stimulation, Pain, Functional performance

Brief summary

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

DEVICENeuromuscular 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.

Sponsors

University of Brasilia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain levelImmediately after the performance of the functional taskPain 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.

Secondary

MeasureTime frameDescription
Total timeImmediately after the performance of the functional task.The total time (s) during the single-leg heel rise task will be measured using the MuscleLab® system.
Maximal displacementImmediately after the performance of the functional task.The maximal displacement (cm) during the single-leg heel rise task will be measured using the MuscleLab® system.
Total workImmediately after the performance of the functional task.The total work (J) during the single-leg heel rise task will be measured using the MuscleLab® system.
Total powerImmediately after the performance of the functional task.The total power (W) during the single-leg heel rise task will be measured using the MuscleLab® system.
Number of repetitionsImmediately after the performance of the functional task.The number of repetitions completed during the single-leg heel rise task will be recorded using the MuscleLab® system.
Peripheral oxygen extractionImmediately after the performance of the functional task.Oxygen extraction of the periarticular ankle muscles will be assessed using near-infrared spectroscopy, with the sensor positioned on the skin over the lateral gastrocnemius muscle during the single leg heel rise task. Variations in oxy- and deoxy-hemo/myoglobin (O₂Hb and HHb, respectively) will be recorded in arbitrary units at a sampling frequency of 25 Hz.
Maximal Achilles tendon displacementImmediately after the performance of the functional task.Maximal Achilles tendon displacement (%) will be measured using a transducer positioned over the myotendinous junction of the gastrocnemius muscles, secured to a specific support, during the single leg heel rise task. Maximal displacement will be determined based on the change in Achilles tendon length relative to its resting length.
Lenght of achilles tendonBaseline (prior to Block A only)The total and free length (cm) of the Achilles tendon will be measured using portable ultrasonography.
Thickness of achilles tendonBaseline (prior to Block A only)The thickness (mm) of the Achilles tendon will be measured using portable ultrasonography.
Cross-sectional area of achilles tendonBaseline (prior to Block A only)The cross-sectional area (cm²) of the Achilles tendon will be measured using portable ultrasonography.
Presence of neovascularization of the Achilles tendonBaseline (prior to Block A only)The presence of neovascularization of the Achilles tendon will be assessed using portable ultrasonography.
Elastic modulusBaseline (prior to Block A only)The median elastic modulus (kPa) of the Achilles tendon will be measured using shear wave elastography.
Shear wave velocityBaseline (prior to Block A only)The median shear wave velocity (m/s) of the Achilles tendon will be measured using shear wave elastography.
DepthBaseline (prior to Block A only)The measurement depth (cm) of the Achilles tendon during elastography assessment will be recorded using shear wave elastography.
Isometric strengthBaseline (prior to Block A only)Isometric strength will be assessed using an isokinetic dynamometer, based on peak isometric torque (N/m) during plantar flexion at 0°.

Countries

Brazil

Contacts

CONTACTJoão LQ Durigan, PhD
joaodurigan@gmail.com+55 61 3107-8450
CONTACTJosé RS Júnior, PhD
joserobertofisio@gmail.com+55 61 3107-8450

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026