Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 11, 2022
Date Accepted: Nov 2, 2022
Date Submitted to PubMed: Nov 3, 2022
Percutaneous Bioelectric Current Stimulation (PBCS) in the Treatment of Chronic Achilles tendinopathy. Protocol for a Double-Blind, Placebo-Controlled Randomized Multicenter Trial
ABSTRACT
Background:
Overall, it must be concluded that no gold standard exists for the treatment of chronic AT, and that treatments are protracted and mostly unsatisfactory. Given the high prevalence and unsatisfactory treatment options, there is a significant medical need for more effective conservative treatment options, especially those that improve long-term Achilles tendon regeneration.
Objective:
The purpose of this study is to investigate the therapeutic effects of percutaneous bioelectric current stimulation (PBCS) on Achilles tendinopathy (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 NRS), return to sports, and use of emergency medication.
Results:
Study began in May 2021. As of March 2022, we randomized 48 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. Clinical Trial: DRKS, DRKS00017293. Registered 1. February 2022. Retrospectively registered, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017293
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