Randomized multicenter follow-up trial on the effect of radiotherapy for plantar fasciitis (painful heels spur) depending on dose and fractionation – a study protocol

Radiation Oncology

Christian Ruebe³  Stefan Graeber¹  Benjamin Prokein³  Marcus Niewald³  Henrik Holtmann² 

[1] Institute of Medical Biometrics, Epidemiology and Medical Informatics, Saarland University Hospital, Kirrberger Str. 1, Homburg, D-66421, Germany;Department of Oral and Maxillofacial Surgery, University Hospital of Duesseldorf, Moorenstr. 5, Duesseldorf, D-40225, Germany;Department of Radiotherapy and Radiooncology, Saarland University Hospital, Kirrberger Str. 1, Homburg, D-66421, Germany

关键词: Randomized multicenter trial;    Low dose radiotherapy;    Plantar fasciitis;    Painful heel spur;   

Others  :  1149965
DOI  :  10.1186/s13014-015-0327-6

 received in 2014-02-27, accepted in 2015-01-05,  发布年份 2015

【 摘 要 】

Background

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.

Methods

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.

Trial registration

Current trial registration at German Clinical Trials Register with the number DRKS00004458 webcite

【 授权许可】

   
2015 Holtmann et al.; licensee BioMed Central.

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