TECAR in the Management of Early Postpartum Perineal Pain.

NCT07730372 | Completed

• 1 other identifier: NKBBN/380/2022
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pain; pelvic floor; postpartum; physiotherapy; radiofrequency

Outcome Measures

Primary Outcomes (1)

• Pain level

  Pain level at rest, while sitting, and while walking was assessed using the Numeric Rating Scale (NRS; 0-10), with higher scores indicating greater pain. Changes in pain levels over time were compared between groups.

  At baseline (up to 36 hours postpartum), the day after each intervention (second and third postpartum days), the highest pain level weekly postpartum (from first to 6th week later).

Secondary Outcomes (7)

• Discomfort level

  At baseline (up to 36 hours postpartum), the day after each intervention (second and third postpartum days), the highest discomfort level weekly postpartum (from first to 6th week later).

• Pain within the groups

  At baseline (up to 36 hours postpartum), the day after each intervention (second and third postpartum days), the highest pain level weekly postpartum (from first to 6th week later).

• Analgesics intake

  At baseline (up to 36 hours postpartum), the day after each intervention (second and third postpartum days), the total weekly dose of paracetamol and ibuprofen during all postpartum period (from week 1 to 6).

• Incontinence Severity Index

  At baseline and 6-8 weeks postpartum.

• Pelvic Floor Muscle Function

  At baseline and 6-8 weeks postpartum.

Study Arms (3)

INT

EXPERIMENTAL

Real TECAR intervention - two treatments

Device: TECAR - Capacitive and Resistive Energy Transfer

SHAM

SHAM COMPARATOR

Sham TECAR intervention - two treatments

Device: Sham TECAR

CON

NO INTERVENTION

Control group with no intervention, recruited separately. Participants received 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.

Interventions

TECAR - Capacitive and Resistive Energy Transfer DEVICE

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.

INT

Sham TECAR DEVICE

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.

SHAM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• vaginal birth (including assisted brith - forcebs or vacuum)
• perineal injury (tear or episiotomy)
• presence of perineal pain
• no contraindications to TECAR therapy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

University Clinical Center

Gdansk, Pomeranian, 80-214, Poland

Location

Related Publications (3)

• Gonzalez-Gutierrez MD, Lopez-Garrido A, Cortes-Perez I, Obrero-Gaitan E, Leon-Morillas F, Ibanez-Vera AJ. Effects of Non-Invasive Radiofrequency Diathermy in Pelvic Floor Disorders: A Systematic Review. Medicina (Kaunas). 2022 Mar 17;58(3):437. doi: 10.3390/medicina58030437.

  PMID: 35334613 BACKGROUND

• Bretelle F, Fabre C, Golka M, Pauly V, Roth B, Bechadergue V, Blanc J. Capacitive-resistive radiofrequency therapy to treat postpartum perineal pain: A randomized study. PLoS One. 2020 Apr 27;15(4):e0231869. doi: 10.1371/journal.pone.0231869. eCollection 2020.

  PMID: 32339169 BACKGROUND

• Sierenska J, Sotomska Z, Madej-Lukasiak D, Waz P, Grzybowska ME. The Use of Capacitive and Resistive Energy Transfer in Postpartum Pain Management in Women after Perineal Trauma. J Clin Med. 2023 Sep 20;12(18):6077. doi: 10.3390/jcm12186077.

  PMID: 37763017 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Model Details: This single-centre, pragmatic, superiority trial compared three parallel groups. Participants were randomized to either the intervention (INT) or sham (SHAM) group, while a separate no-intervention control group (CON) was recruited subsequently without randomization to observe the natural course of postpartum recovery. The study was conducted at a university-based centre. Randomization was performed using a computer-generated simple randomization sequence. The principal investigator individually allocated participants to either the INT or SHAM group after the first assesment to avoid bias. After completion of recruitment for the randomized groups, an additional no-intervention control group (CON) was recruited using the same eligibility criteria but without randomization. This group was included to describe the natural course of postpartum recovery over the study period.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 28, 2026
• Study Start: July 21, 2022
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available upon reasonable request, subject to approval by the corresponding author and in accordance with applicable ethical and data protection regulations.
• Access Criteria: De-identified IPD, together with the study protocol and statistical analysis plan, will be available to qualified researchers upon reasonable request. Requests should be directed to the corresponding author and will be reviewed to ensure that the proposed use is scientifically sound and complies with ethical and data protection regulations. Data will be shared through a secure electronic transfer following approval of the request.

Locations

PL (1)