TECAR in the Management of Early Postpartum Perineal Pain.

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.

Conditions

• Perineal Injury
• Perineal Pain
• Vaginal Delivery
• Instrumental Delivery
• Episiotomy
• Pelvic Floor Physical Therapy

Interventions

DEVICE

TECAR - Capacitive and Resistive Energy Transfer

The study group received an intervention consisting of two phases on the first and second postpartum days. In the first phase, the CET low pulse mode was used for drainage purposes on the abdomen to stimulate the chyle cistern. The phase lasted 3 min and the applicator was applied three times at 6 points for 10 s. In the second phase, using an applicator on the perineum, two types of pulses were applied: RET and CET, both in the low-pulse mode. The RET mode was used for 5 min with circular movements (mobile function) in the perineal area. The CET mode was applied for 10 min with an immobilized applicator (static application). Participants received also standard postpartum care. Pain management consisted of ibuprofen (up to 1,200 mg/day) and paracetamol (up to 4,000 mg/day), administered as needed according to standard clinical practice. Cold packs were also recommended when indicated.

DEVICE

Sham TECAR

The sham group received the same intervention as the study group using a device paused, while still producing characteristic sounds. Participants received also standard postpartum care. Pain management consisted of ibuprofen (up to 1,200 mg/day) and paracetamol (up to 4,000 mg/day), administered as needed according to standard clinical practice. Cold packs were also recommended when indicated.

Sponsors & Collaborators

• Medical University of Gdansk

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-21

Primary Completion

2023-09-14

Completion

2023-09-14

Countries

• Poland

Study Locations