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

Henrik Holtmann, Marcus Niewald, Benjamin Prokein, Stefan Graeber, Christian Ruebe

BackgroundAn 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/methodsControlled, prospective, two-arm phase III-multicenter trial: Standard arm: single fractions of 1.0 Gy applied two times a week, total dose of 6.0 Gy (total therapy time: 3 weeks) Experimental arm: single fractions of 0.5 Gy applied 3 times a week, total dose of 6.0 Gy (total therapy time: 4 weeks)Number of patients for each investigation arm: 120 (statistical power calculation)Main inclusion criteria: Age¿>¿= 40 years Clinical and radiologically diagnosed painful heel spur (plantar fasciitis) Current symptoms for at least 6 monthsMain exclusion criteria: Former local trauma, surgery or radiotherapy of the heel Pregnant or breastfeeding women Pre-existing severe psychiatric or psychosomatic disorderMethodsAfter 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 registrationCurrent trial registration at German Clinical Trials Register with the number DRKS00004458.