Hypothesis / aims of study
Postpartum recovery remains understudied, despite being a universal physical and psychosocial process experienced daily by millions of women worldwide. Perineal trauma after vaginal birth is common, often causing pain that disrupts care, breastfeeding, and bonding [1]. Medications may be insufficient and carry risks, prompting interest in non-pharmacological options such as radiofrequency therapy (TECAR) [2]. To date, the short-term effect of TECAR therapy in the first days postpartum has been investigated in two studies; however, no study yet assessed its impact on pain and discomfort parameters throughout the entire postpartum period [3]. This study aimed to evaluate the effect of two TECAR sessions administered within the first 48 hours after delivery on the reduction of perineal pain and discomfort during a 6-8 week postpartum follow-up.
Study design, materials and methods
This was a randomized controlled two-parallel-arm, double blind trial with a control group recruited separately. The study was conducted at the university-based clinical center from August 2022 to September 2023, with ethics approval. Participants with perineal trauma and pain following vaginal birth were randomized to the TECAR therapy (athermic dose) or a sham intervention. A separate control group without intervention was recruited later. Data collection encompassed demographics, birth details, analgesic consumption, pelvic floor function, perineal pain, and discomfort scores measured using the Numeric Rating Scale. Outcomes were assessed during hospitalization daily, weekly postpartum, and at 6–8 weeks after birth. Pain trajectories were examined using linear mixed models for group, time, and group × time interaction effects.
Results
A total of 183 participants were included: 62 in INT (intervention) group, 62 in CON (control) group, and 59 in SHAM group. The follow-up response rate was 52% and was accounted for in the analysis. Mean age did not differ across groups (30.5 years, p=0.761). Body weight differed statistically significantly (p=0.006). Baseline mean pain score was 3.38 (95% CI: 2.91–3.86), with higher pain in INT (4.56±2.01) vs. CON (3.39±2.2) (β=1.18, p<0.001), but no difference SHAM (3.66±2.04) vs. CON (β=0.30, p=0.340).
The largest pain reduction occurred between weeks 3 and 6 postpartum (all p<0.001). LMM analysis showed significant effects of group and time (both p<0.001), but no group × time interaction (p=0.19), indicating similar pain reduction trends. No statistically significant differences were found in group × time interactions for any pain or discomfort parameters. Paracetamol weekly intake peaked occasionally at later points in INT and SHAM but was not statistically significant after adjustment for multiple comparisons and large standard deviations. Ibuprofen weekly intake was significantly lower in INT and SHAM than CON at first and second week (all p<0.01); other variables were not statistically significant. No side effects of the TECAR therapy were observed.
Interpretation of results
To our knowledge, this study is the first to examine the effects of TECAR therapy on perineal pain throughout the entire puerperium. The findings suggest that two sessions administered at an athermic dose were not more effective than sham or control interventions in reducing postpartum pain or discomfort during this period. Modifications to the intervention protocol by increasing the number of treatments, using a thermal dose, or extending session duration might improve both statistical significance and clinical relevance.