Evaluation of the effect of low-intensity pulsed ultrasound in pain and dysfunction for knee osteoarthritis: a double-blind, randomized controlled trial protocol

Abstract

Background Osteoarthritis (OA) is the most prevalent joint disorder among musculoskeletal conditions. Non-surgical treatment is the conventional therapy for knee OA (KOA). Given the simplicity, feasibility, and effectiveness of physical therapy, it has become a widely used treatment. Ultrasound therapy is recommended for the treatment of pain and dysfunction caused by OA. However, a lack of scientific evidence of high-quality ultrasound treatment of OA still remains. Therefore, we want to analyze whether a combined treatment regimen using low-intensity pulsed ultrasound (LIPUS) can enhance the efficacy of conventional therapy, thus improving symptoms in patients with KOA. Methods This randomized controlled trial aims to recruit 34 patients diagnosed with knee osteoarthritis that meet the Altman clinical diagnostic criteria for KOA and are aged ≥ 38 years. The patients will be randomized in a 1:1 ratio into two groups: a low-intensity pulsed ultrasound treatment group and a sham ultrasound treatment control group. The treatment will last for 2 weeks, with five sessions per week. Study endpoints will be evaluated at baseline, on the day of the last intervention, and one month after the intervention. The main outcome measures will be the Western Ontario and McMaster Universities’ scores. Secondary outcome indicators will be the numerical pain rating scale, the Lequesne scale, the time up and go test, and the range of motion (ROM) of the knee. An intention-to-treat analysis will be performed for dropouts and missing data. Discussion By analyzing patients with OA that undergo or not ultrasound intervention, we will determine whether LIPUS can serve as an adjuvant treatment to enhance the efficacy of physical therapy. If ultrasound treatment plays a synergistic role with physical therapy in ameliorating symptoms in patients with knee OA, it may serve as a low-cost intervention to retard structural progression and alleviate KOA symptoms. Trial registration: The trial was registered on the Chinese Clinical Trial Registry platform (chictr.org.cn) on 03/22/2023, with the registration ID ChiCTR2300069643.