Pelvic PainPhase 2NCT06921174
Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain
A Phase 2 study testing Use of the "Crescendo 2" Intravaginal Device and Classical Perineal Massage Therapy in people with Pelvic Pain, run by Instituto Sexológico Murciano at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- Use of the "Crescendo 2" Intravaginal Device and Classical Perineal Massage Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 27 Mar 2025to 31 Aug 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Instituto Sexológico Murciano
Murcia, Murcia, 30007
Monica Sosa Cabrera, MSc, +34685131637, investigacion@isemu.es
About this study
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.
- Conditions
- Pelvic Pain
- Being tested
- Use of the "Crescendo 2" Intravaginal Device, Classical Perineal Massage Therapy
- Keywords
- postpartum pelvic pain
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the "Crescendo 2" Intravaginal DeviceDevice
Self-administered perineal massage at home with Crescendo device.
Three times per week, 10 minutes each session, over a 12-week period.
Classical Perineal Massage TherapyProcedure or surgery
Performed manually by a pelvic floor physiotherapist.
One 30-minute session per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Classical Perineal Massage Therapy | Active comparator | Performed manually by a pelvic floor physiotherapist.
One 30-minute session per week for 12 weeks. Receives: Procedure: Classical Perineal Massage Therapy |
| Use of the "Crescendo 2" Intravaginal Device | Experimental | Self-administered perineal massage at home.
Three times per week, 10 minutes each session, over a 12-week period. Receives: Device: Use of the "Crescendo 2" Intravaginal Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: First measure week 1 and Last measure week 12
Secondary outcomes (1)
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.
Measured: At the end of the treatment week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start27 Mar 2025
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Type: Randomized Controlled Trial (RCT) Structure: Two parallel groups (random assignment)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Sexológico Murciano
- Sponsor type
- University, hospital or other
- Collaborators
- CIAGO - Center for Comprehensive Gynecology and Obstetrics, Carmen Parra Pilates Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921174
- Sponsor's protocol ID
- C.P. ISM-CRE-2024-01
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11853818Beckmann 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.
PubMed 16437520
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain
- ClinicalTrials.gov ID
- NCT06921174
- Acronym / sponsor ID
- C.P. ISM-CRE-2024-01
- Conditions
- Pelvic Pain
- Keywords
- postpartum pelvic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Instituto Sexológico MurcianoUniversity, hospital or other
- Collaborators
- CIAGO - Center for Comprehensive Gynecology and Obstetrics, Carmen Parra Pilates Center
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Type: Randomized Controlled Trial (RCT) Structure: Two parallel groups (random assignment)
| Arm | Type | Receives |
|---|---|---|
| Classical Perineal Massage Therapy | Active comparator | Procedure: Classical Perineal Massage TherapyPerformed manually by a pelvic floor physiotherapist. One 30-minute session per week for 12 weeks. |
| Use of the "Crescendo 2" Intravaginal Device | Experimental | Device: Use of the "Crescendo 2" Intravaginal DeviceSelf-administered perineal massage at home. Three times per week, 10 minutes each session, over a 12-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- Presence of severe conditions such as:
- Excessive postpartum hemorrhage
- Serious infections
- Respiratory or circulatory complications
- Neurological disorders requiring intensive medical intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of the "Crescendo 2" Intravaginal DeviceSelf-administered perineal massage at home with Crescendo device. Three times per week, 10 minutes each session, over a 12-week period. | Device | Use of the "Crescendo 2" Intravaginal Device |
| Classical Perineal Massage TherapyPerformed manually by a pelvic floor physiotherapist. One 30-minute session per week for 12 weeks. | Procedure or surgery | Classical Perineal Massage Therapy |
Primary outcome
Visual Analogue Scale (VAS) - to assess pain intensity
Time frame: 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).
1 secondary outcome
Clinical Global Impression (CGI) - for overall health status
Time frame: At the end of the treatment week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Results publication: PubMed 11853818Schulz 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.
- Results publication: PubMed 16437520Beckmann 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Use of the "Crescendo 2" Intravaginal Device and Classical Perineal Massage Therapy in people with Pelvic Pain, run by Instituto Sexológico Murciano at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesús Eugenio Dr. Rodríguez Martínez, Phd (+34639238413, jesuseugenio@isemu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) - to assess pain intensity (time frame: First measure week 1 and Last measure week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06921174, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.