Pelvic Pain
Conditions
Keywords
postpartum pelvic pain
Brief summary
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.
Interventions
DEVICEUse 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.
PROCEDUREClassical Perineal Massage Therapy
Performed manually by a pelvic floor physiotherapist. One 30-minute session per week for 12 weeks.
Sponsors
CIAGO - Center for Comprehensive Gynecology and Obstetrics
Carmen Parra Pilates Center
Instituto Sexológico Murciano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Type: Randomized Controlled Trial (RCT) Structure: Two parallel groups (random assignment)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) - to assess pain intensity | First measure week 1 and Last measure week 12 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression (CGI) - for overall health status | At the end of the treatment week 12 | 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. |
Countries
Spain
Contacts
Primary ContactJesús Eugenio Dr. Rodríguez Martínez, Phd
Outcome results
None listed