The Use of TECAR - Capacitive and Resistive Energy Transfer in the Management of Early Postpartum Perineal Pain in Women After Perineal Trauma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Pain level
研究概览
简要总结
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.
详细描述
The study used the Winback Back S1 device (max. 100W, 500 and 300 kHz frequency), which operates in Resistive Energy Transfer (RET) and Capacitive Energy Transfer (CET) modes. To standardize participants' sensations and enhance blinding, a non-thermal current dose was predetermined at 10% intensity for RET and 20% for CET, based on application to the abdominal wall in 20 volunteers. Due to reduced intensity, the treatment duration was prolonged to match the therapeutic efficacy reported with shorter application times and higher intensities, as documented in previous studies on pelvic floor rehabilitation, sports physiotherapy, and data from the TECAR training program. Both the INT and SHAM groups received two TECAR sessions. The CON group underwent the same assessment as INT and SHAM, but was only observed without therapeutic intervention. This allowed for characterization of natural postpartum recovery and comparison with the other groups. Adverse events were assessed systematically after each treatment session by asking all participants about pain, discomfort, skin irritation, burns, or any other unexpected symptoms.
Data collected from participants encompassed both clinical and demographic information, such as age, body mass index (BMI), parity, and delivery-related factors. Information about the duration of the first and second stages of labor, type of pregnancy (singleton or multiple), use of vacuum extraction or forceps, classification of perineal trauma, newborn birthweight and length, fetal position at birth, and the method used for perineal suturing were recorded. The number and type of analgesics (eg, paracetamol, ibuprofen, or others) taken within the first 48 hours postpartum were recorded. The Incontinence Severity Index (ISI) was used to assess urinary incontinence severity, based on symptoms experienced at the end of pregnancy. ISI assesses two dimensions of urinary incontinence: the frequency of leakage (ranging from never = 0 points to every day = 4 points) and the amount of urine leakage (ranging from drops = 1 point to more than small splashes = 3 points).
A physiotherapist trained in pelvic floor health with at least 5 years of experience performed a visual observation of the perineum and a transvaginal pelvic floor muscle examination. This included assessing muscle strength using the Modified Oxford Scale (ranging from 0 to 5), measuring endurance (up to 10 seconds) and response speed (up to 10 rapid contractions), following the abbreviated PERFECT scheme.
Pain and perineal discomfort at rest, while sitting, and while walking were assessed using the Numeric Rating Scale (NRS) at three time points: before the intervention (baseline), and on the day following both the first (post1) and second (post2) intervention sessions. Participants in all groups received a take-home observation sheet for the six weeks of the postpartum period. They recorded the highest levels of perineal pain, discomfort, and the total number of analgesics taken, administered during each of the six postpartum weeks (puerperium1-6). Participants were informed about planned telephone and email communications to arrange the postpartum visit.
A follow-up visit was performed 6 to 8 weeks postpartum at the outpatient clinic, during which pelvic floor muscle function was re-evaluated. Participants were asked to provide information from the postpartum period, including ISI. Those unable to attend in person were asked to email their completed observation sheets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •vaginal birth (including assisted brith - forcebs or vacuum)
- •perineal injury (tear or episiotomy)
- •presence of perineal pain
- •no contraindications to TECAR therapy
排除标准
- •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.
结局指标
主要结局
Pain level
时间窗: 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).
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.
次要结局
- 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.)
- FSFI(6-8 weeks postpartum (in the follow-up assesment).)
- PISQ-IR(6-8 weeks after intervention (follow-up).)
研究者
Joanna Wojtas
MSc
Medical University of Gdansk