Radiotherapy for Ledderhose disease: Results of the LedRad-study, a prospective multicentre randomised double-blind phase 3 trial

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Anneke de Haan, Johanna G.H. van Nes, M. Willemijn Kolff, Peter-Paul van der Toorn, A. Helen Westenberg, Annelies E. van der Vegtf, Henk Groen, Jelle Overbosch, Hans Paul van der Laan, Paul M.N. Werker, Johannes A. Langendijk, Roel J.H.M. Steenbakkers

Published: 19 May 2023

DOI: https://doi.org/10.1016/j.radonc.2023.109718

 

Highlights

• First randomised controlled trial to investigate the efficacy of radiotherapy for Ledderhose disease.
• Radiotherapy for Ledderhose disease results in pain reduction in majority of patients.
• Quality of life improves after radiotherapy for Ledderhose disease and is comparable to the reference population.
• Side effects after radiotherapy for Ledderhose disease are limited.
• The most demanding walking situation for patients with Ledderhose disease, barefoot speed walking, significantly improves after radiotherapy.

 

Abstract

 

Background and purpose

Radiotherapy is considered a treatment option for Ledderhose disease. However, its benefits have never been confirmed in a randomised controlled trial. Therefore, the LedRad-study was conducted.

Materials and methods

The LedRad-study is a prospective multicentre randomised double-blind phase three trial. Patients were randomised to sham-radiotherapy (placebo) or radiotherapy. The primary endpoint was pain reduction at 12 months after treatment, measured with the Numeric Rating Scale (NRS). Secondary endpoints were pain reduction at 6 and 18 months after treatment, quality of life (QoL), walking abilities and toxicity.

Results

A total of 84 patients were enrolled. At 12 and 18 months, patients in the radiotherapy group had a lower mean pain score compared to patients in the sham-radiotherapy group (2.5 versus 3.6 (p = 0.03) and 2.1 versus 3.4 (p = 0.008), respectively). Pain relief at 12 months was 74% in the radiotherapy group and 56% in the sham-radiotherapy group (p = 0.002). Multilevel testing for QoL scores showed higher QoL scores in the radiotherapy group compared to the sham-radiotherapy group (p < 0.001). Moreover, patients in the radiotherapy group had a higher mean walking speed and step rate with barefoot speed walking (p = 0.02). Erythema, skin dryness, burning sensations and increased pain were the most frequently reported side effects. These side effects were generally graded as mild (95%) and the majority (87%) were resolved at 18 months follow-up.

Conclusion

Radiotherapy for symptomatic Ledderhose disease is an effective treatment resulting in a significant pain reduction, improvement of QoL scores and bare feet walking abilities, in comparison to sham-radiotherapy.