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Completed
NCT07730372
TECAR in the Management of Early Postpartum Perineal Pain.
Conditions: Perineal Injury, Perineal Pain, Vaginal Delivery, Instrumental Delivery, Episiotomy, Pelvic Floor Physical Therapy
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 182
Sponsor: Medical University of Gdansk
Location: University Clinical Center Gdansk Pomeranian
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.
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.
Source: ClinicalTrials.gov (NCT07730372). StuddyBuddy aggregates publicly available trial information.