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Radiotherapy is considered a treatment option for Ledderhose disease. However, the added value has never been confirmed in a randomised controlled trial (RCT). Therefore, the main purpose of this study was to investigate the benefit of radiotherapy for Ledderhose disease in a RCT.

The LedRad-study is a prospective, multicenter, randomised, double-blind, phase III trial comparing radiotherapy to sham-radiotherapy (placebo), as treatment for patients with symptomatic Ledderhose disease. The main inclusion criteria were; pain from Ledderhose disease ≥ 2 on the numeric rating scale (NRS), no previous surgery and/or radiotherapy to the affected foot and age ≥ 18 years. Age and gender were used as stratification factors. Radiotherapy consisted of 10 fractions of 3 Gy administered in two separate courses of five daily fractions, with an interval of 10 weeks. Procedures in both groups were identical, except that treatment delivery was simulated for the patients randomised to receive sham-radiotherapy. Unblinding of the treatment was performed 18 months after the end of (sham-)radiotherapy. The primary endpoint was the pain score at 12 months after treatment, measured with the NRS. Secondary endpoints were the pain score at 6 and 18 months after treatment, quality of life (QoL), walking abilities, changes in nodule size, cost-effectiveness and safety/toxicity.

From January 2018 to October 2019, 84 patients (27 men and 57 women) were included in the study. Mean age at time of inclusion was 56 years (range 19 to 75 years). A total number of 130 feet were treated; 65 in the radiotherapy group and 65 in the sham-radiotherapy group, respectively. At 12 and 18 months after treatment, patients from the radiotherapy group had a statistically significant lower mean pain score compared to patients in the sham-radiotherapy group (2.5 vs. 3.6 and 2.2 vs. 3.4 respectively, figure 1). Pain response at 12 months was 74% for the radiotherapy group and 56% for the sham-radiotherapy group. Twelve months after the end of study-treatment QoL scores of the radiotherapy group improved and were comparable to the score of the Dutch general population in the same age category (figure 2). Multilevel testing for QoL scores showed significantly higher QoL scores for the radiotherapy group compared to the sham-radiotherapy group (p<0.001). Also patients from the radiotherapy group had a significantly higher mean walking speed and step rate when walking fast on bare feet (p=0.02).

This study showed that radiotherapy for symptomatic Ledderhose disease results in pain reduction, improvement of QoL scores and improvement of walking abilities. The observation of the large placebo effect in the sham-radiotherapy group is yet unclear and needs further investigation.