Date: Monday, November 6, 2017
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.
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). http://acrabstracts.org/abstract/non-randomized-controlled-trial-to-evaluate-the-effect-of-extracorporeal-shock-wave-therapy-on-digital-ulcers-in-systemic-sclerosis/. Accessed May 23, 2018.
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ACR Meeting Abstracts - http://acrabstracts.org/abstract/non-randomized-controlled-trial-to-evaluate-the-effect-of-extracorporeal-shock-wave-therapy-on-digital-ulcers-in-systemic-sclerosis/