JMIR Res Protoc. 2022 Nov 2. doi: 10.2196/40894. Online ahead of print.
BACKGROUND: The consensus of the optimal treatment strategy for chronic Achilles tendinopathy (AT) is still debated and treatment options are limited. This results in a significant medical need for more effective treatment options.
OBJECTIVE: The aim of this study is to investigate the therapeutic effects of percutaneous bioelectric current stimulation (PBCS) on AT.
METHODS: A multi-center, randomized, double-blind, placebo-controlled clinical trial will be conducted. A total of 72 participants with chronic (>3 months) midpoint AT will be randomized and receive 4 PBCS (either verum or placebo) over 3 weeks. Both groups will complete daily Achilles tendon loading exercises in addition to the intervention. Evaluation sessions will be completed at baseline and intervention (weeks 0-3). Self-reported outcome measures will be completed at the follow-up in weeks 4, 12, 26, 52.Primary outcome: Victorian Institute of Sports Assessment – Achilles Questionnaire(Version: VISA-A) score: Statistical evaluation of intraindividual differences between baseline and 12 weeks after initial treatment after verum therapy compared to control. Secondary outcomes will assess pain disability index (PDI), average pain (11-point numeric rating scale – NRS), return to sports, and use of emergency medication.
RESULTS: Study began in May 2021. As of October 2022, we randomized 66 out of 72 participants. We anticipate completing recruiting in the fourth quarter of 2022 and primary data analysis in the first quarter of 2023.
CONCLUSIONS: The study will evaluate the effects of PBCS on pain, physical function and clinical outcomes.
CLINICALTRIAL: DRKS, DRKS00017293. Registered 1. February 2022. Retrospectively registered, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017293.