TECAR in the Management of Early Postpartum Perineal Pain. | NCT07730372

NCT07730372

Overview

NCT ID: NCT07730372
Lead Sponsor: Medical University of GdanskOTHER
Official Title: The Use of TECAR - Capacitive and Resistive Energy Transfer in the Management of Early Postpartum Perineal Pain in Women After Perineal Trauma.
Brief Summary: The study aimed to evaluate the effect of TECAR (Capacitive and Resistive Energy Transfer) therapy on the level of pain and discomfort in the pelvic floor in women after an episiotomy or perineal tears, during the first two days after a vaginal delivery and during the postpartum period.

The primary outcome of this study was the change in pain level at rest, sitting, and walking measured at baseline, after each intervention, and weekly during the postpartum period, and compared across the INT, SHAM, and CON groups.

The secondary outcomes were:

changes in perineal discomfort in sitting and walking, assessed at baseline, after each intervention, and weekly during the postpartum period, compared between the study groups;

doses of paracetamol and ibuprofen administered in the first days after childbirth and in the subsequent weeks of the postpartum period, compared between the study groups;

changes in ISI scores assessed at baseline and at the 6-8 week follow-up, compared between the study groups;

changes in pelvic floor muscle function, assessed at baseline and at the 6-8 week follow-up, compared between the study groups.

The study was conducted among patients of the University Clinical Center Obstetrics Clinic. Overall 180 patients were included in the study (60 women in the study group, 60 in the control group, and 60 in the sham group). The study was conducted using a double-blind method. Women in the study group received therapy on the 1st and 2nd postpartum day using the Winback BACK 1S device, which emits radiofrequency waves. The treatment time was about 20 minutes. In the sham group, the same study protocol was carried out, but the device was in pause mode, so the patients did not know which group they belonged to throughout the trial. In the control group, recruited separatelt, there was no intervention and only an initial assessment of the pelvic floor and perineal pain. Pain and discomfort at rest, sitting, and walking were assessed before the intervention and two consecutive days after. In addition, a follow-up assessment 6-8 weeks after delivery was performed.

Status and Timeline

Status: Completed
Last Update Posted: Jul 28, 2026Actual
Start Date: Jul 21, 2022Actual
Primary Completion Date: Sep 14, 2023Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

vaginal birth (including assisted brith - forcebs or vacuum)

perineal injury (tear or episiotomy)

presence of perineal pain

no contraindications to TECAR therapy

Exclusion Criteria:

cesarean cection

perineal protection

lack of pain

contraindications to TECAR therapy: presence of electronic devices in the body, coagulation disorders (hemophilia, von Willebrand disease, use of anticoagulants), burns in the examined area, malignancy, severe hypertension or hypotension, and thrombophlebitis.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 182Actual
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: No data available
Locations: University Clinical Center

Similar Studies

Masking Description

Participants were blinded to treatment allocation until completion of the study. To maintain blinding during the intervention, the TECAR device was paused and positioned out of the participant's view, preventing identification of the treatment mode. The device did not include an automated randomization function. Patient-reported outcomes, including perineal pain, discomfort, analgesic use, and the Female Sexual Function Index (FSFI), were self-reported by participants using standardized questionnaires. During the in-hospital assessments, the researcher collecting questionnaire responses was blinded to group allocation and identified participants only by their study ID. Follow-up questionnaires completed remotely during the postpartum period were also self-administered, minimizing the risk of assessor bias. Pelvic floor muscle assessment was performed by the principal investigator, who was aware of group allocation; therefore, this outcome was not assessor-blinded.