Madzia Alex, Agrawal Chirag, Jarit Paddy, Petterson Stephanie, Plancher Kevin, Ortiz Ralph
Department of Biomedical Engineering, University of Cincinnati, Cincinnati, OH 45219, USA.
Sport and Orthopaedic Physical Therapy, Fairfield, CT 06824, USA.
Open Orthop J. 2020;14:176-185. doi: 10.2174/1874325002014010176. Epub 2020 Dec 18.
Sustained Acoustic Medicine (SAM) is an emerging, non-invasive, non-narcotic, home-use ultrasound therapy for the daily treatment of joint pain. The aim of this multi-site clinical study was to examine the efficacy of long-duration continuous ultrasound combined with a 1% diclofenac ultrasound gel patch in treating pain and improving function in patients with knee osteoarthritis.
The Consolidated Standards of Reporting Trials (CONSORT) were followed. Thirty-two (32) patients (18-males, 14-females) 54 years of average age with moderate to severe knee pain and radiographically confirmed knee osteoarthritis (Kellgren-Lawrence (KL) grade II/III) were enrolled for treatment with the SAM device and diclofenac patch applied daily to the treated knee. SAM ultrasound (3 MHz, 0.132 W/cm, 1.3 W) and 6 grams of 1% diclofenac were applied with a wearable device for 4 hours daily for 1 week, delivering 18,720 Joules of ultrasound energy per treatment. The primary outcome was the daily change in pain intensity using a numeric rating scale (NRS 0-10), which was assessed prior to intervention (baseline, day 1), before and after each daily treatment, and after 1 week of daily treatment (day 7). Rapid responders were classified as those patients exhibiting greater than a 1-point reduction in pain following the first treatment. Change in Western Ontario McMaster Osteoarthritis Questionnaire (WOMAC) score from baseline to day 7 was the secondary functional outcome measure. Additionally, a series of daily usability and user experience questions related to devising ease of use, functionality, safety, and effectiveness, were collected. Data were analyzed using t-tests and repeated measure ANOVAs.
The study had a 94% retention rate, and there were no adverse events or study-related complaints across 224 unique treatment sessions. Rapid responders included 75% of the study population. Patients exhibited a significant mean NRS pain reduction over the 7-day study of 2.06-points (50%) for all subjects (n=32, p<0.001) and 2.96-points (70%) for rapid responders (n=24, p<0.001). The WOMAC functional score significantly improved by 351 points for all subjects (n=32, p<0.001), and 510 points for rapid responders (n=24, p<0.001). Over 95% of patients found the device safe, effective and easy to use, and would continue treatment for their knee OA symptoms.
Sustained Acoustic Medicine combined with 1% topical diclofenac rapidly reduced pain and improved function in patients with moderate to severe osteoarthritis-related knee pain. The clinical findings suggest that this treatment approach may be used as a conservative, non-invasive treatment option for patients with knee osteoarthritis. Additional research is warranted on non-weight bearing joints of the musculoskeletal system as well as different topical drugs that could benefit from improved localized delivery.Clinical Trial Registry Number: (NCT04391842).
持续声学医学（SAM）是一种新兴的、非侵入性、非麻醉性的家用超声疗法，用于日常治疗关节疼痛。这项多中心临床研究的目的是检验长时间连续超声联合1%双氯芬酸超声凝胶贴剂治疗膝关节骨关节炎患者疼痛和改善功能的疗效。
遵循试验报告的统一标准（CONSORT）。招募了32名患者（18名男性，14名女性），平均年龄54岁，有中度至重度膝关节疼痛且经影像学证实为膝关节骨关节炎（凯尔格伦-劳伦斯（KL）分级II/III级），使用SAM设备并每日在治疗的膝关节上贴双氯芬酸贴剂进行治疗。使用可穿戴设备每天施加SAM超声（3兆赫，0.132瓦/平方厘米，1.3瓦）和6克1%双氯芬酸，持续4小时，共1周，每次治疗传递18720焦耳超声能量。主要结局是使用数字评分量表（NRS 0 - 10）评估的疼痛强度每日变化，在干预前（基线，第1天）、每日每次治疗前后以及每日治疗1周后（第7天）进行评估。快速反应者定义为首次治疗后疼痛减轻超过1分的患者。从基线到第7天西安大略和麦克马斯特大学骨关节炎问卷（WOMAC）评分的变化是次要功能结局指标。此外，收集了一系列与设备易用性、功能、安全性和有效性相关的每日可用性和用户体验问题。使用t检验和重复测量方差分析进行数据分析。
该研究的保留率为94%，在224次独特的治疗过程中没有不良事件或与研究相关的投诉。快速反应者占研究人群的75%。在为期7天的研究中，所有受试者（n = 32，p < 0.001）的平均NRS疼痛显著降低2.06分（50%），快速反应者（n = 24，p < 0.001）降低2.96分（70%）。所有受试者（n = 32，p < 0.001）的WOMAC功能评分显著提高351分，快速反应者（n =
