High-energy dose of therapeutic ultrasound in the treatment of patellar tendinopathy: protocol of a randomized placebo-controlled clinical trial

BACKGROUND: Patellar tendinopathy is an extremely debilitating condition and its treatment usually requires a combination of clinical approaches. Therapeutic ultrasound (TUS) is one of the most available electrophysical agent in rehabilitation settings; however, there is also a lack of high-quality studies that test different dosimetric aspects of TUS. Thus, the purpose of this study is to evaluate the short-, medium-, and long-term effects of the combination of high-energy TUS with a rehabilitation program for patellar tendinopathy. METHODS: This will be a randomized, placebo-controlled trial with blinding of patients, assessors, and therapist. The setting is an outpatient physical therapy clinic. We will recruit 66 participants (male and female) aged between 18 and 40 years and presenting with patellar tendinopathy. A treatment combining high-energy dose TUS and a rehabilitation program for patellar tendinopathy will be delivered twice a week for 8 weeks. The control group will receive the same treatment, but with a placebo TUS. The effectiveness of the intervention will be measured at the beginning (baseline), midpoint (4 weeks), and end of treatment (8 weeks), as well as at 3- and 6-months post-treatment. Primary outcomes will be pain intensity (visual analogue scale, VAS), and VISA-P questionnaire and primary time points will be baseline (T0) and the end of the program (T2). Also, IPAQ-short form questionnaire, muscle strength (manual dynamometry), 2D kinematics, pain pressure threshold (PPT) algometry, thermography, and magnetic resonance imaging (MRI) will be collected. DISCUSSION: TUS will be applied in an attempt to enhance the results obtained with the rehabilitation program proposed in this study, as well as stimulate some repair responses in individuals undergoing treatment for patellar tendinopathy, which in turn may optimize and improve treatment programs for patellar tendinopathy as well as to establish new guidelines for the application of TUS. TRIAL REGISTRATION: This study was prospectively registered at April-3rd-2018 and updated at September-1st-2019 in the Brazilian Registry of Clinical Trials (REBEC) under the registration number: RBR-658n6w.