Holtmann Henrik, Niewald Marcus, Prokein Benjamin, Graeber Stefan, Ruebe Christian
Department of Radiotherapy and Radiooncology, Saarland University Hospital, Kirrberger Str. 1, D-66421, Homburg, Germany.
Department of Oral and Maxillofacial Surgery, University Hospital of Duesseldorf, Moorenstr. 5, D-40225, Duesseldorf, Germany.
Radiat Oncol. 2015 Jan 20;10:23. doi: 10.1186/s13014-015-0327-6.
An actual clinical trial showed the effect of low dose radiotherapy in painful heel spur (plantar fasciitis) with single doses of 1.0 Gy and total doses of 6.0 Gy applied twice weekly. Furthermore, a lot of animal experimental and in vitro data reveals the effect of lower single doses of 0.5 Gy which may be superior in order to ease pain and reduce inflammation in patients with painful heel spur. Our goal is therefore to transfer this experimentally found effect into a randomized multicenter trial.
STUDY DESIGN/METHODS: This was a controlled, prospective, two-arm phase III-multicenter trial. The standard arm consisted of single fractions of 1.0 Gy applied two times a week, for a total dose of 6.0 Gy (total therapy time: 3 weeks). The experimental arm consisted of single fractions of 0.5 Gy applied 3 times a week, for a total dose of 6.0 Gy (total therapy time: 4 weeks). Following a statistical power calculation, there were 120 patients for each investigation arm. The main inclusion criteria were: age > = 40 years, clinical and radiologically diagnosed painful heel spur (plantar fasciitis), and current symptoms for at least 6 months. The main exclusion criteria were: former local trauma, surgery or radiotherapy of the heel; pregnant or breastfeeding women; and a pre-existing severe psychiatric or psychosomatic disorder.
After approving a written informed consent the patients are randomized by a statistician into one of the trial arms. After radiotherapy, the patients are seen after six weeks, after twelve weeks and then every twelve weeks up to 48 weeks. Additionally, they receive a questionnaire every six weeks after the follow-up examinations up to 48 weeks. The effect is measured using the visual analogue scale of pain (VAS), the calcaneodynia score according to Rowe and the SF-12 score. The primary endpoint is the pain relief three months after therapy. Patients of both therapy arms with an insufficient result are offered a second radiotherapy series applying the standard dose (equally in both arms). This trial protocol has been approved by the expert panel of the DEGRO as well as by the Ethics committee of the Saarland Physicians' chamber.
Current trial registration at German Clinical Trials Register with the number DRKS00004458.
一项实际临床试验显示了低剂量放疗对足跟痛性骨刺（足底筋膜炎）的疗效，单次剂量为1.0 Gy，总剂量为6.0 Gy，每周应用两次。此外，大量动物实验和体外数据显示，较低的单次剂量0.5 Gy可能在缓解足跟痛性骨刺患者的疼痛和减轻炎症方面更具优势。因此，我们的目标是将这一实验发现的疗效转化为一项随机多中心试验。
研究设计/方法：这是一项对照、前瞻性、双臂III期多中心试验。标准组为每周两次给予单次剂量1.0 Gy，总剂量为6.0 Gy（总治疗时间：3周）。试验组为每周三次给予单次剂量0.5 Gy，总剂量为6.0 Gy（总治疗时间：4周）。经过统计功效计算，每个研究组有120例患者。主要纳入标准为：年龄≥40岁，临床和影像学诊断为足跟痛性骨刺（足底筋膜炎），且当前症状持续至少6个月。主要排除标准为：既往足跟局部创伤、手术或放疗史；孕妇或哺乳期妇女；以及既往存在严重精神或身心疾病。
在获得书面知情同意后，由统计学家将患者随机分配到其中一个试验组。放疗后，在6周、12周时对患者进行检查，然后每12周检查一次，直至48周。此外，在随访检查后的每6周直至48周，他们都会收到一份问卷。使用视觉模拟疼痛量表（VAS）、根据罗伊评分的跟骨痛评分以及SF - 12评分来衡量疗效。主要终点是治疗三个月后的疼痛缓解情况。两个治疗组中疗效不佳的患者将接受第二个标准剂量的放疗疗程（两组相同）。本试验方案已获得德国放射肿瘤学会专家小组以及萨尔州医师协会伦理委员会的批准。
目前在德国临床试验注册中心注册，注册号为DRKS00004458。
