Study Comparing Traditional Perineal Massage to Crescendo 2 Intravaginal Device for Reducing Postpartum Perineal Pain

What this Trial Is About

Researchers are evaluating two methods to reduce postpartum perineal pain in women who have had a vaginal delivery within the past 6 weeks to 12 months. This Phase 2 randomized study compares traditional perineal massage therapy performed by a pelvic floor physiotherapist with the use of a self-administered intravaginal device called Crescendo 2. The study focuses on women experiencing pelvic pain coded as GA34.01 in the ICD-11 system and aims to assess the effectiveness of these approaches in easing pain after childbirth. Participants are randomly assigned to one of two groups. The first group receives classical perineal massage therapy, where a pelvic floor physiotherapist performs one 30-minute session per week for 12 weeks. The second group uses the Crescendo 2 intravaginal device at home, performing self-administered perineal massage three times per week for 10 minutes each session over the same 12-week period. This design allows a direct comparison between professional therapy and home device use. During the study, pain intensity is measured using the Visual Analog Scale VAS at the start and end of the 12-week treatment. Additionally, overall health status is evaluated with the Clinical Global Impression Scale at the end of the treatment period. Participants will be monitored throughout the study to record these outcomes and ensure safety. The total participation duration is 12 weeks, with assessments focusing on changes in perineal pain and wellness.

Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain