Karel Hurt1, Frantisek Zahalka2, Michael Halaska3, Ivana Rakovicova4, Aneta Krajcova5. 1. Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University, Prague, Czech Republic - hurt@infoprague.com. 2. Sports Motoric Laboratory, Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic. 3. Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University, Prague, Czech Republic. 4. OBGYN Department Amedeana Prague, Prague, Czech Republic. 5. Department of Plastic Surgery, First Faculty of Medicine, Charles University, Prague, Czech Republic.
Abstract
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<0.01) and CST (P<0.01) were observed at all three follow-ups. At all assessments, pain reduction was always >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<0.01); CST P<0.01). CONCLUSIONS:ESWT seems to reduce pain perception in our treatment group. Thus, we are encouraged to explore this technique further. CLINICAL REHABILITATION IMPACT: The method is easily replicable, inexpensive, and without known side effects.
RCT Entities:
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<0.01) and CST (P<0.01) were observed at all three follow-ups. At all assessments, pain reduction was always >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<0.01); CST P<0.01). CONCLUSIONS: ESWT seems to reduce pain perception in our treatment group. Thus, we are encouraged to explore this technique further. CLINICAL REHABILITATION IMPACT: The method is easily replicable, inexpensive, and without known side effects.