Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study.
Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study.
复制标题
DOI：
10.2174/1874325002014010176
复制
发表时间：
2020
期刊：
影响因子：
--
通讯作者：
Ortiz R
中科院分区：
文献类型：
--
作者：
Madzia A;Agrawal C;Jarit P;Petterson S;Plancher K;Ortiz R
持续声学医学（SAM）是一种新兴的，非侵入性，非麻醉性，家用超声治疗，用于关节疼痛的日常治疗。这项多中心临床研究的目的是检查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。试验报告的统一标准（Consort）。32例平均年龄54岁、患有中度至重度膝关节疼痛和经影像学证实的膝关节骨关节炎（Kelling-Lawrence（KL）II/III级）的患者（18例男性，14例女性）入组接受SAM器械和双氯芬酸贴剂每日贴敷治疗膝关节的治疗。使用可穿戴设备应用SAM超声（3 MHz，0.132 W/cm 2，1.3 W）和6 g 1%双氯芬酸，每天4小时，持续1周，每次治疗提供18，720焦耳的超声能量。主要结局是使用数字评定量表（NRS 0-10）评估疼痛强度的每日变化，在干预前（基线，第1天）、每日治疗前后和每日治疗1周后（第7天）进行评估。快速反应者被归类为首次治疗后疼痛减轻1分以上的患者。从基线到第7天，西安大略麦克马斯特骨关节炎问卷（WOMAC）评分的变化是次要功能结局指标。此外，还收集了一系列与设计易用性、功能性、安全性和有效性相关的日常可用性和用户体验问题。使用t检验和重复测量方差分析来分析数据。该研究的留存率为94%，在224次独特治疗中没有出现不良事件或研究相关投诉。快速反应者占研究人群的75%。在7天的研究中，所有受试者（n=32，p<0.001）和快速反应者（n=24，p<0.001）的平均NRS疼痛均显著减轻2.06分（50%）。所有受试者的WOMAC功能评分显著改善了351分（n=32，p<0.001），快速反应者改善了510分（n=24，p<0.001）。超过95%的患者认为该器械安全、有效且易于使用，并将继续治疗膝关节OA症状。在中度至重度骨关节炎相关膝关节疼痛患者中，持续声学药物联合1%局部双氯芬酸可迅速减轻疼痛并改善功能。临床研究结果表明，这种治疗方法可以作为一种保守的，非侵入性的治疗选择，膝关节骨关节炎患者。对肌肉骨骼系统的非承重关节以及不同的局部药物进行额外的研究是必要的，这些药物可以从改进的局部给药中受益。临床试验注册编号：（NCT 04391842）。
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/cm2, 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).