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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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Brazil
University of Brasilia
RECRUITING
Brasília
Contact Information
Primary
João LQ Durigan, PhD
joaodurigan@gmail.com
+55 61 3107-8450
Backup
José RS Júnior, PhD
joserobertofisio@gmail.com
+55 61 3107-8450
Time Frame
Start Date: 2026-01-06
Estimated Completion Date: 2029-12-30
Participants
Target number of participants: 30
Treatments
No_intervention: 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.
Experimental: 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.
Placebo_comparator: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: University of Brasilia

This content was sourced from clinicaltrials.gov