The efficacy of radial shockwave therapy compared with sham shockwave therapy in insertional Achilles tendinopathy. A randomised controlled trial

Radial shockwave therapy (rSWT): rSWT will be administered by an adequately trained physiotherapist. The participant will receive a 3000-shock dose of rSWT (Chattanooga device) applied to the most painful area on the affected side Achilles tendon. Gel will be used to conduct pressure waves to the tendon. Intensity of application will start on two bars of pressure, with frequency set to continuous and eight per second. The target self-reported pain will be >4/10 until the highest tolerable pain (numerical pain rating scale, 0=no pain, 10=worst pain imaginable). If self-reported pain drops below 5/10 the rSWT probe will be moved to a different region within the region of interest (area 2cm squared surrounding the starting location). If the pain remains below 5/10 at all parts within the region of interest the rSWT pressure setting will be progressed from two bar of pressure (this will always be the starting point) up to and including five bar of pressure (the maximum in the machine being used) so as to achieve the desired self-reported pain output. This process will be repeated as necessary until the shock dose of 3000 is completed (at 10 Hz, so the treatment lasts for 5 minutes). Participants will receive an identical rSWT treatment on three occasions (baseline, and approx. week 1 and 2), each separated by a approximaly 7 days (minimum 5 days and maximum 10 days). Post rSWT treatment: Immediately after the rSWT, participants will be asked whether they believe they were in the intervention or placebo group. After that, an appropriately trained researcher, who is blind to treatment allocation will deliver advice and a 12-week exercise program to all participants. This includes an evidence-based and progressively loaded exercise protocol for Achilles tendinopathy, education about physical activity modification and resumption, and advice about progressing and regressing exercise load, based on a pain monitoring model. The researcher will also provide education about Achilles tendinopathy (pathology, pain, risk factors, prognosis, treatments, recovery times). Participants will be reviewed by the researcher at Imaging at Olympic Park (IOP) at weeks 1 and 2 weeks (when repeat shockwave is applied) to modify the exercise as required (e.g. progress load, modify technique). The researcher will have a teleconference (Zoom) meeting with participants at week 6 to ask whether they have any questions or issues with the exercise or education intervention. Additionally, participants will be provided with basic online exercise videos and education and the researchers contact details that they can use at any time. Participants will be advised to refrain from using other physical therapy interventions and non-steroidal anti-inflammatory medications but will be advised to take paracetamol (up to 4g/day) for pain relief as required. Details of the exercise program: a) who is administering the program: physiotherapist (@ baseline with further progressions and guidance @ 1, 2 weeks, and zoom support at 6 weeks). ie participants will be followed up @ 5 weeks via Zoom. Participants will also be sent a weekly email encouraging them to complete the exercises and report any issues they may be having (if they express they are having issues a researcher will call them to discuss) b) the mode of administration: independently at home. c) the level of intensity: will be adjusted by the participants themselves based on pain and repetitions in reserve. They will be advised to do 15 repetitions x 4 sets, once a day for three times a week. If they experience less than 5/10 pain and have 2 reps in reserve, then they will be advised to add weights in 5kgs increments. If pain is >5/10 they will be advised to revert to an isometric version of the exercise d) the frequency/duration of program, 15 repetitions x 4 sets, once a day for three times a week for 12 weeks. e) the exercises include standing knee straight and knee bent isotonic (eccentric and conentric) calf raises f) exercise progression: Participants will progress and regress exercise themselves based on criteria outlined above. They will also be reviewed by the researcher at Imaging at Olympic Park (IOP) at 1 and 2 weeks to administer subsequent rSWT sessions and to modify the exercise as required (e.g. progress load, modify technique). There will also be a brief Zoom session at 6 weeks to check progress, check exercises and provide advice. Details of the education program: a) who administers the education: physiotherapist (@ baseline with further reinforcement and guidance @ 1, 2 weeks, and a Zoom meeting at 6 weeks, as well as weekly email support [opportunity to ask questions and voice concerns]) b) the mode of administration: Face to face supported by videos and education leaflets. c) the frequency/duration of program: 12 weeks. single session at the beginning of the program and then with further reinforcement and guidance @ week 6 via a Zoom meeting and weekly email support). d) the education program will be delieverd in 15-20 minutes in the first session. Strategies to monitor adherence: adherence will be assessed via self report questionnaire at 6 and 12 weeks (via email or text link to a Qualtrics survey).

径向冲击波疗法（Radial Shockwave Therapy, rSWT）：将由经过充分培训的物理治疗师实施该疗法。受试者将接受3000次冲击波剂量的径向冲击波治疗（使用Chattanooga设备），治疗位点选取患侧跟腱疼痛最显著的区域。将使用耦合剂将压力波传导至跟腱。治疗强度初始设置为2bar压力，频率设为连续模式，每秒8次。治疗目标为受试者自我报告的疼痛评分＞4/10，直至达到受试者可耐受的最高疼痛程度（数字疼痛评分量表：0分为无痛，10分为可想象的最剧烈疼痛）。若受试者自我报告的疼痛评分降至5/10以下，则将径向冲击波探头移至感兴趣区域内的其他位点（感兴趣区域为起始位点周围2cm²的范围）。若感兴趣区域内所有位点的疼痛评分均低于5/10，则将径向冲击波的压力设置从初始的2bar（始终为起始压力）逐步提升至5bar（所用设备的最大压力值），以达到预期的受试者自我报告疼痛水平。该过程将根据需要重复进行，直至完成3000次冲击波剂量的治疗（治疗频率为10Hz，单次治疗时长为5分钟）。受试者将接受3次相同的径向冲击波治疗，分别于基线期、第1周及第2周进行，每次治疗间隔约7天（最短5天，最长10天）。

治疗后流程：径向冲击波治疗结束后即刻，将询问受试者是否认为自己被分配至干预组或安慰剂组。随后，一名对治疗分配不知情且经过充分培训的研究人员将为所有受试者提供指导及为期12周的运动方案。该方案包含针对跟腱炎的循证渐进负荷运动方案、关于体力活动调整与恢复的健康教育，以及基于疼痛监测模型的运动负荷增减指导建议。研究人员还将为受试者提供跟腱炎相关健康教育，内容包括病理机制、疼痛表现、危险因素、预后情况、治疗方式及恢复周期。

受试者将分别于第1周和第2周（即再次接受冲击波治疗时）在奥林匹克公园影像中心（Imaging at Olympic Park, IOP）接受研究人员的随访，以根据需要调整运动方案（例如调整运动负荷、修正动作技巧）。研究人员将于第6周与受试者进行Zoom电话会议，询问其在运动或健康教育干预过程中是否存在任何疑问或问题。此外，受试者将获得基础的线上运动视频及教育资料，以及研究人员的联系方式，以便其随时咨询。受试者将被建议避免使用其他物理治疗干预措施及非甾体类抗炎药物，但可根据需要服用对乙酰氨基酚（每日最大剂量为4g）以缓解疼痛。

运动方案详情：
a) 方案实施者：物理治疗师（基线评估时提供指导，第1、2周提供方案调整与进一步指导，第6周提供Zoom线上支持）。即受试者将在第5周通过Zoom接受随访。此外，研究人员每周将向受试者发送邮件，鼓励其完成运动并报告任何相关问题（若受试者反馈存在问题，研究人员将致电与其沟通）。
b) 实施方式：受试者在家独立完成。
c) 强度等级：由受试者根据自身疼痛情况及预留重复次数自行调整。受试者需每日完成1组15次重复动作，共4组，每周训练3次。若受试者疼痛评分＜5/10且预留2次重复次数，则可按每次5kg的增量增加负重；若疼痛评分＞5/10，则需恢复至该运动的等长收缩版本。
d) 方案频率与时长：每日1组15次重复动作，共4组，每周训练3次，总时长12周。
e) 运动内容：包括站立位膝伸直与膝屈曲等张训练（离心与向心收缩的提踵动作）。
f) 运动进度调整：受试者将根据上述标准自行调整运动的负荷与减量。他们还将在第1、2周于奥林匹克公园影像中心（IOP）接受研究人员的随访，以开展后续的径向冲击波治疗并根据需要调整运动方案（例如调整运动负荷、修正动作技巧）。第6周还将通过Zoom进行简短会议，以评估进度、检查动作并提供指导建议。

健康教育方案详情：
a) 健康教育实施者：物理治疗师（基线评估时开展首次教育，第1、2周进行强化与指导，第6周通过Zoom会议进行跟进，同时每周提供邮件支持[可随时提问与反馈顾虑]）。
b) 实施方式：线下面对面授课，辅以教学视频与健康教育手册。
c) 方案频率与时长：总时长12周。初始阶段开展单次授课，第6周通过Zoom会议进行强化与指导，并辅以每周邮件支持。
d) 首次健康教育授课时长为15-20分钟。

依从性监测策略：将通过自我报告问卷评估受试者的治疗依从性，分别于第6周和第12周通过邮件或短信发送Qualtrics调查链接。