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

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Pain
• Intervention / Treatment: Procedure: Classical Perineal Massage Therapy; Device: Use of the "Crescendo 2" Intravaginal Device

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jesús Eugenio Dr. Rodríguez Martínez, Phd; Phone Number: +34639238413; Email: jesuseugenio@isemu.es

Study Locations

• Spain
  • Murcia, Spain, 30007
    • Recruiting
    • Instituto Sexológico Murciano
    • Contact: Monica Sosa Cabrera, MSc; Phone Number: +34685131637; Email: investigacion@isemu.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women aged 18 years or older.
• Residing in the Region of Murcia.
• Having had a vaginal delivery between 6 weeks and 12 months prior to enrollment.
• Presenting postpartum perineal pain, coded in ICD-11 as GA34.01.
• Have not received any prior treatment for this condition.

Exclusion Criteria:

• Presence of severe conditions such as:
• Excessive postpartum hemorrhage
• Serious infections
• Respiratory or circulatory complications
• Neurological disorders requiring intensive medical intervention
• Currently under pharmacological treatment for pelvic pain.
• Active vaginal infections.
• Expressed refusal to participate or inability to comply with study procedures.
• Women with episiotomy may participate only if there were no complications such as severe infection or hemorrhage following the procedure.

Willingness to participate and to follow the study protocol.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Classical Perineal Massage Therapy; Performed manually by a pelvic floor physiotherapist. One 30-minute session per week for 12 weeks.	Procedure: Classical Perineal Massage Therapy; Performed manually by a pelvic floor physiotherapist. One 30-minute session per week for 12 weeks.
Experimental: Use of the "Crescendo 2" Intravaginal Device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	First measure week 1 and Last measure week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the end of the treatment week 12

Collaborators and Investigators

• Sponsor: Instituto Sexológico Murciano
• Collaborators: CIAGO - Center for Comprehensive Gynecology and Obstetrics; Carmen Parra Pilates Center

Publications and helpful links

General Publications

• Beckmann MM, Garrett AJ. Antenatal perineal massage for reducing perineal trauma. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD005123. doi: 10.1002/14651858.CD005123.pub2.
• Schulz KF, Grimes DA. Generation of allocation sequences in randomised trials: chance, not choice. Lancet. 2002 Feb 9;359(9305):515-9. doi: 10.1016/S0140-6736(02)07683-3.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2025
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: postpartum pelvic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain
• Other Study ID Numbers: C.P. ISM-CRE-2024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No