Study Protocol for low-temperature radiofrequency coblation micro-tenotomy for the treatment of Achilles tendinopathy: a multicentre, prospective randomized controlled clinical trial.

Abstract

Background: Achilles tendinopathy (AT) is a common musculoskeletal disorder that causes pain, swelling, and stiffness in the heel region and can significantly impact an individual's quality of life. Despite being a prevalent problem, no gold standard treatment for AT exists. This has led to exploring novel treatment options, one of which is low-temperature radiofrequency coblation micro-tenotomy. Radiofrequency micro-tenotomy is a minimally invasive procedure that uses low-temperature energy to disrupt tissue and induce controlled damage to promote healing. This technology has shown promising results in treating various musculoskeletal conditions, including AT. Methods: The study will involve 48 participants diagnosed with AT, randomly allocated to either the treatment or control group. The treatment group will receive a single session of radiofrequency micro-tenotomy with standard endoscopic debridement, while the control group will only receive endoscopic debridement. The primary outcome measure will be symptoms measured using the Victorian Institute of Sport Assessment-Achilles (VISA-A) tool. Ultrasonographic changes to the Achilles tendon will also be documented alongside object measures of calf muscle strength. Participants will be assessed at baseline, 1 week, 12 weeks, 6 months, and 1 year post-treatment. The study hypothesizes that radiofrequency micro-tenotomy will significantly improve Achilles tendon function, thickness, vascularity, and calf muscle strength. The results of this trial could potentially establish radiofrequency micro-tenotomy as a data-proven treatment option for AT. Discussion: This study aims to address the limited treatment options available for AT by investigating a minimally invasive approach. If successful, radiofrequency microtenotomy could offer a simple and less invasive management option for this condition. Additionally, the results of this trial may influence future research and treatment protocols for other tendinopathy regions and strategies for regenerative medicine. Overall, this randomized controlled trial of radiofrequency microtenotomy for AT aims to provide valuable insights into the effectiveness and safety of this treatment option. The findings of this study have the potential to improve outcomes and quality of life for individuals with this chronic, debilitating condition; thus it is crucial to consider this research when developing treatment plans for future Achilles tendinopathy patients. Trial registration: ClinicalTrials.gov (NCT06342245). Registered on 2ndApril 2024