OBJECTIVE: To assess the efficacy of intravaginal electrical stimulation (IVES) or placebo in women with chronic pelvic pain (CPP) with no apparent cause. STUDY DESIGN: A double-blind, crossover, randomized clinical trial in which 26 women were randomly allocated to active (group I, n = 15) or placebo (group II, n = 11) IVES. All women underwent 10 30-minute, twice-weekly sessions. The groups were then crossed over for a further 10 sessions. Pain was evaluated using a visual analog scale (VAS) before and after each series. RESULTS: At the end of the first series, 5 of 11 women who initiated with the placebo had a VAS pain score > 3 (p = 0.0253); however, when they crossed over to active IVES, only 1 had a VAS pain score > 3 at the end of the series (p = 0.0143). In the 15 women who initiated with active IVES, 2 had a score > 3 at the end of the series (p = 0.0005); however, when they crossed over to the placebo, 3 had a VAS pain score > 3 at the end of treatment (p = 0.0833). After the 2 sessions, 54.6% who initiated with placebo and 80% who initiated with active IVES had a VAS pain score < 3. CONCLUSION:Intravaginal electrical stimulation was more effective than a placebo in alleviating pain in women with CPP.
RCT Entities:
OBJECTIVE: To assess the efficacy of intravaginal electrical stimulation (IVES) or placebo in women with chronic pelvic pain (CPP) with no apparent cause. STUDY DESIGN: A double-blind, crossover, randomized clinical trial in which 26 women were randomly allocated to active (group I, n = 15) or placebo (group II, n = 11) IVES. All women underwent 10 30-minute, twice-weekly sessions. The groups were then crossed over for a further 10 sessions. Pain was evaluated using a visual analog scale (VAS) before and after each series. RESULTS: At the end of the first series, 5 of 11 women who initiated with the placebo had a VAS pain score > 3 (p = 0.0253); however, when they crossed over to active IVES, only 1 had a VAS pain score > 3 at the end of the series (p = 0.0143). In the 15 women who initiated with active IVES, 2 had a score > 3 at the end of the series (p = 0.0005); however, when they crossed over to the placebo, 3 had a VAS pain score > 3 at the end of treatment (p = 0.0833). After the 2 sessions, 54.6% who initiated with placebo and 80% who initiated with active IVES had a VAS pain score < 3. CONCLUSION: Intravaginal electrical stimulation was more effective than a placebo in alleviating pain in women with CPP.