II–1 Compliance of Low-Intensity Pulsed Ultrasound (LIPUS) for Fresh Fractures

Abstract

Introduction: Some reports showed that low intensity pulsed ultrasound (LIPUS) could stimulate mesenchymal stromal cell (MSC) differentiation into osteo/chondrocyte in vitro. The purpose of this study was to investigate whether LIPUS treatment combined with cell therapy could affect cartilage regeneration in rats which have poor intrinsic repair capacity.Materials and Methods: Eight weeks old male Wistar rats were used in this study. An osteochondral defect, 1mm in diameter, was created on both sides of femora trochlea. MSCs were injected into right knee joint after 4 weeks from defect operation and rats were divided into 2 interventions: without or with LIPUS treatment. Two days after intra-articular injection, the rats with LIPUS were subjected to LIPUS treatment according to parameters borrowed from those for bone fracture treatment, 20 min/d, 5 d/wk for 4 weeks, to both knee joints. The rats were euthanized and their knee joints were isolated after 4 weeks post intra-articular injection. The isolated knee joints were therefore divided into 4 groups: Control group, LIPUS group, MSC group and LIPUS+MSC (MSCL) group. The osteochondral defect area was histologically evaluated with Wakitani cartilage repair score and immunohistochemically stained for type II collagen.Results: Four weeks after intra-articular injection, the defect area was filled with repair tissue which wasn't hyaline cartilage in Control group. In LIPUS, MSC and MSCL groups, the Wakitani cartilage repair score was increased compared with Control group, although there were not clear differences among these 3 groups in the score. In LIPUS and MSCL groups, we observed type II collagen expression in wide range of repair tissue compared with MSC group.Discussion: Our results indicated that LIPUS treatment or MSC injection could stimulate cartilage regeneration, while there might be little interactive effect between these 2 treatments in vitro.

Design evolution enhances patient compliance for low-intensity pulsed ultrasound device usage

“…In LIPUS trials with a successful outcome,5–7,12–16 wherein the study met the protocol-defined end point, the average compliance was 88% (range: 72%–100%), whereas for trials where the primary end point was not met, the compliance was 54% (range: 43%–95%) 17–20. Moreover, eight out of ten trials with patient compliance higher than 72% reported a successful outcome,5–7,12–16 whereas two clinical trials that reported poor patient compliance resulted in unsuccessful outcomes. In the two trials that had high compliance but did not result in a successful outcome,17,18 other factors may have confounded the results.…”

Pulsed ultrasound for bone regeneration – outcomes and hurdles in the clinical application: a systematic review

“…Therefore, motivation and dedication of the patients plays an indispensable role in the study outcome. Certain factors, such as age and fracture site, could significantly affect the adherence to the prescribed LIPUS protocol (Matsubara et al, 2015). The detailed description of patient compliance in the reviewed studies is summarised in Table 1-3. There is a considerable variability in documentation regarding patients' compliance in LIPUS clinical trials.…”

“…It is not always clear, though, whether the active minutes were counted only when the device was in direct skin contact, as it was described in some studies (Emami et al, 1999;Zacherl et al, 2009). Overall, there is a trend towards positive regenerative outcomes of the LIPUS application in clinical trials with increasing patient device-application compliance (Gopalan et al, 2020;Maurya et al, 2019;Namera et al, 2020;Nolte et al, 2001;Roussignol et al, 2012;Santana-Rodríguez et al, 2019;Schofer et al, 2010;Tsumaki et al, 2004). Studies, where around 30 % of the patients performed less than 50 % of LIPUS applications found LIPUS ineffective (Emami et al, 1999;TRUST Investigators writing group et al, 2016;Simpson et al, 2017).…”

“…A profound impact on bone formation was observed in the LIPUS-active group, whereas a relapse in a first distal metatarsal articular angle 6 weeks after treatment was reported in the placebo group. The active support of patients and communication with the medical personnel seem to improve the compliance significantly, favouring LIPUS therapy (Arimoto et al, 2019;Gopalan et al, 2020;Maurya et al, 2019;Namera et al, 2020;Patel et al, 2015;Santana-Rodríguez et al, 2019;Tsumaki et al, 2004;Zacherl et al, 2009). This should be considered when planning a clinical trial.…”