Extracorporeal shock wave therapy for treatment of vulvodynia: a prospective, randomized, double-blind, placebo-controlled study

Autor: Frantisek Zahalka, Ivana Rakovičová, Karel Hurt, Aneta Krajcová, Michael Halaska
Rok vydání: 2020
Předmět:
Zdroj: European journal of physical and rehabilitation medicine. 56(2)
ISSN: 1973-9095
Popis: BACKGROUND Currently, there are no effective therapy strategies for idiopathic, non-organic vulvodynia in women. ESWT (extracorporeal shock wave therapy) is a nonsurgical/noninvasive technique widely used to treat musculoskeletal diseases, muscle spasticity and hypertonia, renal and biliary calculi and urological disorders. AIM We examined the effects of ESWT on vulvodynia in women. DESIGN A prospective, randomized, double-blind, placebo-controlled study was conducted between 2015 and 2018 following a feasibility study. SETTING Obstetrics and Gynecology Hospital departments. POPULATION The study included 62 women with vulvodynia for at least 3 months. METHODS The women were randomly assigned to either a treatment group (N.=31) or a placebo group (N.=31). The patients in the treatment group received perineally applied ESWT weekly (3000 pulses each for four consecutive weeks). The energy flux density was 0.25 mJ/mm2, frequency 4 Hz, focus zone 0-30 mm, therapeutic efficacy 0-90 mm, stand-off II. The device used was a standard electromagnetic shock wave unit with a focused shock wave handpiece. The position of the shock wave transducer was changed six times after every 500 pulses. Patients in the placebo group underwent the same treatment procedure, but the handpiece was provided with a placebo stand-off that disabled energy transmission. Subjective pain was self-evaluated by each patient using two tools before and after treatment: a 10 cm linear visual analogue scale (VAS, 0-10) and a cotton-swab test (CST, Goetsch scale 0-4). Follow-ups were done 1, 4, and 12 weeks post-ESWT. RESULTS In all, 61 women completed the study. We tested for differences in the VAS and CST within and between the treatment and placebo groups. The testing was between before treatment and particular follow-up. We found significant changes in the treatment group. Reductions in VAS (P 30%. In the placebo group there were no statistically significant changes between before and after treatment. There were no differences between the treatment and placebo groups before treatment but statistically significant differences at all three follow-ups (VAS P
Databáze: OpenAIRE