A Phase 2 interventional study of Use of the "Crescendo 2" Intravaginal Device and Classical Perineal Massage Therapy in Pelvic Pain, sponsored by Instituto Sexológico Murciano. Recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by Instituto Sexológico Murciano · Phase 2, Interventional, and Treatment
GA34.01 postpartum, a randomized design with a parallel group structure will be applied, randomly assigning participants into two groups. The first group will receive the traditional perineal massage therapy, while the second group will use the intravaginal device "Crescendo 2." In this study, a pre- and post-intervention evaluation will be conducted, using the Visual Analog Scale (VAS) as the primary outcome measure and the Clinical Global Impression Scale as the secondary outcome measure.
375 studies on the registry are indexed under Pelvic Pain; 89 are open to participants now.
This study's planned enrollment of 140 is above the median of 60 across 277 interventional studies indexed under Pelvic Pain.
Browse Pelvic Pain studies →Instituto Sexológico Murciano is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Willingness to participate and to follow the study protocol.
Exclusion Criteria:
-
Performed manually by a pelvic floor physiotherapist. One 30-minute session per week for 12 weeks.
Procedure: Classical Perineal Massage Therapy
Self-administered perineal massage at home. Three times per week, 10 minutes each session, over a 12-week period.
Device: Use of the "Crescendo 2" Intravaginal Device
Self-administered perineal massage at home with Crescendo device. Three times per week, 10 minutes each session, over a 12-week period.
Performed manually by a pelvic floor physiotherapist. One 30-minute session per week for 12 weeks.
Visual Analogue Scale (VAS) - to assess pain intensity
The \*\*Visual Analogue Scale (VAS)\*\* will be used as the \*\*primary outcome measure\*\*. It consists of a horizontal line approximately 10 centimeters long. At each end of the line are the extreme expressions of pain: on the left, "no pain," and on the right, "worst imaginable pain." This tool allows us to measure the intensity of pain with high reproducibility between observers. Visual Analogue Scale (VAS): The Visual Analogue Scale is a psychometric response scale used to measure pain intensity. It typically consists of a 10-centimeter horizontal line anchored by two verbal descriptors: "no pain" (score = 0) and "worst imaginable pain" (score = 10). Minimum score: 0 (no pain) Maximum score: 10 (worst imaginable pain) Interpretation: Higher scores indicate worse outcomes (i.e., more intense pain).
Time frame: First measure week 1 and Last measure week 12
Clinical Global Impression (CGI) - for overall health status
The Clinical Global Impression Scale (CGI) will be used as the secondary outcome measure. The Global Impression Scale (GIC) is a subjective tool used to assess the overall perceived change in a patient's health status, particularly in clinical studies involving various conditions and treatments. Clinical Global Impression - Change (CGI-C) Scale: The Clinical Global Impression - Change scale is a clinician-rated tool used to assess changes in a patient's condition over time, relative to baseline. Minimum score: 1 (very much improved) Maximum score: 7 (very much worse) Interpretation: Lower scores indicate better outcomes (i.e., greater clinical improvement), while higher scores indicate worsening.
Time frame: At the end of the treatment week 12
Plan to share: No
Started Mar 2025 (actual). Primary completion is estimated for Jun 2025, 2 months after the start.
Of 14 phase 2 interventional studies under Pelvic Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 29. This study's planned 2 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Instituto Sexológico Murciano