Optimized Protocol for Extracorporeal Shock Wave Therapy on Digital Ulcers in Systemic Sclerosis

Tomonori Ishii¹, Yasushi Kawaguchi², Osamu Ishikawa³, Hiromitsu Takemori⁴, Naruhiko Takasawa⁵, Hitoshi Kobayashi⁶, Yuichi Takahashi⁷, Hidekata Yasuoka⁸, Takao Kodera⁹, Osamu Takai¹⁰, Izaya Nakaya¹¹, Tomomasa Izumiyama¹², Hiroshi Fujii¹³, Yukiko Kamogawa¹³, Yuko Shirota¹³, Tsuyoshi Shirai¹³, Yoko Fujita¹⁴, shinichiro saito¹⁵, Hiroaki Shimokawa¹⁶ and Hideo Harigae¹³, 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, ⁴Aomori Prefectural Central Hospital, Aomori, Japan, ⁵Department of Internal Medicine, Tohoku Medical and Pharmaceutical University Wakabayashi Hospital, Sendai, Japan, ⁶Iwate Medical University Hospital, Morioka, Japan, ⁷Ｙｕ　Ｆａｍｉｌｙ　Ｃlinic, Sendai, Japan, ⁸Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, tokyo, Japan, ⁹Division of Hematology and Rheumatology, Tohoku Medical and Pharmaceutical University, Sendai, Japan, ¹⁰Osaki Citizen Hospital, Sendai, Japan, ¹¹Department of Nephrology and Rheumatology, Iwate Prefectural Central Hospital, Morioka, Japan, ¹²Higashisendai Rheumatic Disease Clinic, Sendai, Japan, ¹³Department of Hematology and Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Japan, ¹⁴Department of Hematolgy and Rheumatolgy, Tohoku University Graduate School of Medicine, Sendai, Japan, ¹⁵IMS Meirikai Sendai General Hospital, Sendai, Japan, ¹⁶Department of Cardiovascular medicine, Tohoku University Graduate School of Medicine, Sendai, Japan

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Systemic sclerosis, treatment and ulcers

Session Information

Date: Tuesday, October 23, 2018

Title: Systemic Sclerosis and Related Disorders – Clinical Poster III

Session Type: ACR Poster Session C

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

Background/Purpose: Extracorporeal shock wave therapy (ESWT) at low energy has been shown to be effective for digital ulcers in systemic sclerosis (SSc) in our study reported at ACR last year. However, studies to confirm treatment protocols with the most therapeutic effect have not been satisfactorily performed. We aimed to determine the optimal treatment period by comparing the number of cutaneous ulcers before and after treatment.

Methods: The study enrolled 60 patients with SSc and refractory digital ulcers. Of these, 30 were treated with ESWT and 30 received conventional treatment. ESWT treatment was performed once a week for 8 weeks and the results were observed for 4 additional weeks. The total number of ulcers and the number of large ulcers (defined as having a diameter ≥5 mm) were evaluated. During the treatment period, outcomes were assessed every week for 8 weeks and then evaluated during a 4-week observation period, after treatment completion. The visual analog scale (VAS) for pain as a patient-reported outcome (PRO) was also evaluated.

Results: The ulcers decreased by 78.34% in the ESWT group and 20.94% in the conventional treatment group at 8 weeks, and the difference was significant (p=0.0001). However, the ulcers decreased by 71.85% in the ESWT group and 53.75% in the conventional treatment group at 12 weeks (observation period). No further improvement was seen following the treatment period in the ESWT group, and the difference in efficacy from the conventional treatment group decreased during the observation period. Large ulcers alone decreased by 84.21% in the ESWT group and 52.78% in the conventional treatment group at 8 weeks, and the difference was not significant. However, the improvement in VAS pain scores at 8 weeks was 43.96% in the ESWT group and -16.60% in the conventional treatment group (p=0.0817). The pain VAS scores did not decrease significantly probably because of insufficient improvement in large ulcers.

Conclusion: ESWT treatment was discontinued at 8 weeks, but some ulcers remained. Persistence of large ulcers had a significant influence on VAS pain scores. Treatment protocols may require continued ESWT until ulcer disappearance, especially for large ulcers.

Disclosure: T. Ishii, ONO PHARMACEUTICAL, 8,Janssen Pharmaceutical, 8,Astellas Pharma, 8,Sanofi KK, 8; Y. Kawaguchi, None; O. Ishikawa, None; H. Takemori, None; N. Takasawa, None; H. Kobayashi, None; Y. Takahashi, None; H. Yasuoka, None; T. Kodera, None; O. Takai, None; I. Nakaya, None; T. Izumiyama, 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, Takemori H, Takasawa N, Kobayashi H, Takahashi Y, Yasuoka H, Kodera T, Takai O, Nakaya I, Izumiyama T, Fujii H, Kamogawa Y, Shirota Y, Shirai T, Fujita Y, saito S, Shimokawa H, Harigae H. Optimized Protocol for Extracorporeal Shock Wave Therapy on Digital Ulcers in Systemic Sclerosis [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/optimized-protocol-for-extracorporeal-shock-wave-therapy-on-digital-ulcers-in-systemic-sclerosis/. Accessed .

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