Non-Randomized Controlled Trial to Evaluate the Effect of Extracorporeal Shock Wave Therapy on Digital Ulcers in Systemic Sclerosis

Tomonori Ishii¹, Yasushi Kawaguchi², osamu ishikawa³, naruhiko takasaawa⁴, takao kodera⁵, hidekata yasuoka⁶, yuichi takahashi⁷, osamu takai⁸, Izaya Nakaya⁹, Hiroshi Fujii¹⁰, Yukiko Kamogawa¹⁰, Yuko Shirota¹⁰, Tsuyoshi Shirai¹⁰, Yoko Fujita¹¹, shinichiro saito¹², Hiroaki Shimokawa¹³ and Hideo Harigae¹⁰, ¹Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai, Japan, ²Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, ³Department of Dermatology, Gunma University Graduate School of Medicine, gunma, Japan, ⁴Department of Internal Medicine, Tohoku Medical and Pharmaceutical University Wakabayashi Hospital, Sendai, Japan, ⁵Division of Hematology and Rheumatology, Tohoku Medical and Pharmaceutical University, Sendai, Japan, ⁶Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, tokyo, Japan, ⁷Ｙｕ　Ｆａｍｉｌｙ　Ｃlinic, Sendai, Japan, ⁸Osaki Citizen Hospital, Sendai, Japan, ⁹Department of Nephrology and Rheumatology, Iwate Prefectural Central Hospital, Morioka, Japan, ¹⁰Department of Hematology and Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Japan, ¹¹Department of Hematolgy and Rheumatolgy, Tohoku University Graduate School of Medicine, Sendai, Japan, ¹²IMS Meirikai Sendai General Hospital, Sendai, Japan, ¹³Department of Cardiovascular medicine, Tohoku University Graduate School of Medicine, Sendai, Japan

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Raynaud's phenomenon, Systemic sclerosis, treatment and ulcers

Session Information

Date: Monday, November 6, 2017

Title: Systemic Sclerosis, Fibrosing Syndromes and Raynaud's – Clinical Aspects and Therapeutics Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Patients with systemic sclerosis (SSc) often display Raynaud’s phenomenon, which causes digital skin ulcers. Since these ulcers are not associated with autoimmune factors, conventional immunosuppressive therapies, vasodilators, and anticoagulants are often ineffective. Extracorporeal shock wave therapy (ESWT) at low energy is shown to be effective in stimulating numerous growth factors endogenously, inducing angiogenesis and healing of injuries and wounds. This study evaluated ESWT for treatment of refractory skin ulcers caused by SSc and assessed its efficacy and safety.

Methods: We enrolled 60 patients with SSc and refractory digital ulcers with no response to intravenous prostaglandin E1 therapy at least 4 weeks. Of these, 30 were treated with ESWT and 30 received conventional treatment. Patients in the conventional treatment group were permitted to use any currently available therapies. Patients in the ESWT group continued pre-study treatments.

Results: The mean decrease in the number of ulcers at 8 weeks was 4.47 in the ESWT group and 0.83 in the conventional treatment group and the difference was significant (p<0.0001). The proportion of subjects whose total number of ulcers decreased by 70% or more at 8 weeks was 26.7% in the conventional treatment group and 70.0% in the ESWT group and this was also significant (p<0.0008). The average number of new ulcers in the 8 weeks after the start of treatment was 1.57 in the conventional group and 0.23 in the ESWT group. No serious adverse events associated with ESWT were reported during the study period.

Conclusion: After 8 weeks, ESWT demonstrated clinically meaningful improvement in SSc patients with refractory digital ulcers. This treatment is well-tolerated and minimally invasive, can be repeated without adverse effects, and requires no anesthesia. Overall, the results of our study suggest that ESWT is a novel and efficacious treatment that can be added to pharmacologic therapy.

Disclosure: T. Ishii, Chugai, Ono, Pfizer, Mitsubishi-Tanabe, Astellas, 8; Y. Kawaguchi, None; O. ishikawa, None; N. takasaawa, None; T. kodera, None; H. yasuoka, None; Y. takahashi, None; O. takai, None; I. Nakaya, None; H. Fujii, None; Y. Kamogawa, None; Y. Shirota, None; T. Shirai, None; Y. Fujita, None; S. saito, None; H. Shimokawa, None; H. Harigae, None.

To cite this abstract in AMA style:

Ishii T, Kawaguchi Y, ishikawa O, takasaawa N, kodera T, yasuoka H, takahashi Y, takai O, Nakaya I, Fujii H, Kamogawa Y, Shirota Y, Shirai T, Fujita Y, saito S, Shimokawa H, Harigae H. Non-Randomized Controlled Trial to Evaluate the Effect of Extracorporeal Shock Wave Therapy on Digital Ulcers in Systemic Sclerosis [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/non-randomized-controlled-trial-to-evaluate-the-effect-of-extracorporeal-shock-wave-therapy-on-digital-ulcers-in-systemic-sclerosis/. Accessed .

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