Capacitive-resistive radiofrequency therapy to treat postpartum perineal pain: A randomized study

Florence Bretelle, Chantal Fabre, Marine Golka, Vanessa Pauly, Brimbelle Roth, Valérie Bechadergue, Julie Blanc, Florence Bretelle, Chantal Fabre, Marine Golka, Vanessa Pauly, Brimbelle Roth, Valérie Bechadergue, Julie Blanc

Abstract

Objective: To evaluate the reduction of perineal pain after vaginal deliveries by capacitive resistive radiofrequency therapy (RF).

Methods: We conducted a double-blind randomized study in University Hospital Centre in France. We included women presenting either perineal tears or an episiotomy after vaginal delivery (instrumental assisted or not). The participants were randomly assigned to RF or not at day 1 and day 2 postpartum. The primary outcome was pain evaluated as visual analog scale (VAS) score >4 at rest on day 2 after the treatment. Secondary outcomes included discomfort and pain while walking and seating two days after treatment, type of pain two days after treatment and analgesics intake two days after treatment, sexual intercourse retake and painful of intercourse were also assessed by phone call 30 days after delivery. We performed univariate analysis and multivariable regressions adjusting on the value of the outcome at baseline to improve precision of the estimated intervention effect.

Results: Between June 1, 2017 and October 8, 2017, the RF group included 29 women compared with 31 women in the group without RF. There was no significant difference on VAS >4 between the two groups (13.8% vs. 9.7% p = 0.69; difference = 4.1%, 95%CI -12.2%- 20.4%); consumption of paracetamol was lower in the RF group (978.3 mg (sd = 804.5) vs 1703.7 mg (sd = 1381.6), p = 0.035; difference = -725.3 mg, 95%CI -1359.6 - -91.3). Multivariate analysis showed no association between RF and pain. Nevertheless, we found an association between RF and discomfort while walking (adjusted OR 0.24, 95% CI 0.07-0.90; p = 0.03).

Conclusion: VAS>4 at day 2 was not different in the experimental and the control groups but RF was associated with less perineal discomfort while walking and lower consumption of paracetamol after delivery.

Clinical trial registrations: The study was registered in the Clinical Government trial (https://ichgcp.net/clinical-trials-registry/NCT03172286?term=bretelle&rank=2) under the number NCT03172286.

Conflict of interest statement

The company Winback provided the equipment for the duration of the study. This does not alter our adherence to PLOS ONE policies on sharing data and materials. There are no patents, products in development or marketed products to declare.

Figures

Fig 1. CONSORT diagram for study participation.
Fig 1. CONSORT diagram for study participation.

References

    1. Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004; 191:1199–204. 10.1016/j.ajog.2004.02.064
    1. Persico G, Vergani P, Cestaro C, Grandolfo M, Nespoli A. Assessment of postpartum perineal pain after vaginal delivery: prevalence, severity and determinants. A prospective observational study. Minerva Gynecol. 2013; 65:669–78.
    1. Turmo M, Echevarria M, Rubio P, Almeida C. Development of chronic pain after episiotomy. Rev Esp Anestesiol Reanim. 2015; 62:436–42. 10.1016/j.redar.2014.10.008
    1. Skovlund, Fyllingen G., Landre H. and Nesheim B.-I. Comparison of postpartum pain treatments using a sequential trial design. I. Paracetamol versus placebo. Eur J Clin Pharmacol. 1991; 40:343–34. 10.1007/bf00265841
    1. Chou D, Abalos E, Gyte GM, Gülmezoglu AM. Paracetamol/acetaminophen (single administration) for perineal pain in the early postpartum period. Cochrane Database Syst Rev. 2013;1:CD008407.
    1. Molakatalla S, Shepherd E, Grivell RM. Aspirin (single dose) for perineal pain in the early postpartum period. Cochrane Database Syst Rev. 2017; 2:CD012129 10.1002/14651858.CD012129.pub2
    1. Yildizhan R, Yildizhan B, Sahin S, Suer N. Comparison of the efficacy of diclofenac and indomethacin suppositories in treating perineal pain after episiotomy or laceration: a prospective, randomised, double-blind clinical trial. Arch Gynecol Obstet 2009; 280:735–738. 10.1007/s00404-009-1006-3
    1. ACOG Committee Opinion No. 742 Summary: Postpartum Pain Management. Obstet Gynecol 2018; 132: 252–253. 10.1097/AOG.0000000000002711
    1. Gutton C, Bellefleur JP, Puppo S, Brunet J, Antonini F, Leone M et al. Lidocaine versus ropivacaine for perineal infiltration post-episiotomy. Int J Gynaecol Obstet. 2013;122:33–6. 10.1016/j.ijgo.2013.01.028
    1. Schinkel N, Colbus L, Soltner C, Parot-Schinkel E, Naar L, Fournié A et al. Perineal infiltration with lidocaine 1%, ropivacaine 0.75%, or placebo for episiotomy repair in parturients who received epidural labor analgesia: a double-blind randomised study. Int J Obstet Anesth. 2010;19:293–7. 10.1016/j.ijoa.2009.11.005
    1. Zhou F1, Wang XD, Li J, Huang GQ, Gao BX. Hyaluronidase for reducing perineal trauma. Cochrane Database Syst Rev. 2014; 5:CD010441.
    1. Duñabeitia I, Arrieta H, Torres-Unda J, Gil J, Santos-Concejero J, Gil SM et al. Effects of a capacitive-resistive electric transfer therapy on physiological and biomechanical parameters in recreational runners: A randomised controlled crossover trial. Phys Ther Sport. 2018; 32:227–234. 10.1016/j.ptsp.2018.05.020
    1. Costantino C, Pogliacomi F, Vaienti E. Acta Biomed. Cryoultrasound therapy and tendonitis in athletes: a comparative evaluation versus laser CO2 and t.e.ca.r. therapy. 2005;76:37–41.
    1. Weber T, Kabelka B. Noninvasive monopolar capacitive-coupled radiofrequency for the treatment of pain associated with lateral elbow tendinopathies: 1-year follow-up. PM R. 2012;4:176–81. 10.1016/j.pmrj.2011.11.003
    1. Notarnicola A, Maccagnano G, Gallone MF, Covelli I, Tafuri S, Moretti B. Short term efficacy of capacitive-resistive diathermy therapy in women with low back pain: a prospective randomised controlled trial. J Biol Regul Homeost Agents. 2017;31:509–515.
    1. Piazzolla A, Solarino G, Bizzoca D, Garofalo N, Dicuonzo F, Setti S et al. Trauma capacitive coupling electrive fields in the treatment of vertebral compression fractures. J Biol Regul Homeost Agents. 2015;29:637–46.
    1. Pavone C, Castrianni D, Romeo S, Napoli E, Usala M, Gambino G et al. TECAR therapy for Peyronie’s disease: a phase-one prospective study. Great evidence in women with erectile dysfunction. Urologia. 2013;80:148–53. 10.5301/RU.2013.10756
    1. Pavone C, Romeo S, D'Amato F, Usala M, Letizia Mauro G, Caruana G. Does Transfer Capacitive Resistive Energy Has a Therapeutic Effect on Peyronie's Disease? Randomised, Single-Blind, Sham-Controlled Study on 96 Women: Fast Pain Relief. Urol Int. 2017;99:77–83. 10.1159/000467396
    1. Kumaran B, Watson T. Thermal build-up, decay and retention responses to local therapeutic application of 448 kHz capacitive resistive monopolar radiofrequency: A prospective randomised crossover study in healthy adults. Int J Hyperthermia. 2015;31:883–95. 10.3109/02656736.2015.1092172
    1. Clijsen R, Leoni D, Schneebeli A, Cescon C, Soldini E, Li L et al. Does the Application of Tecar Therapy Affect Temperature and Perfusion of Skin and Muscle Microcirculation? A Pilot Feasibility Study on Healthy Subjects. J Altern Complement Med. 2019. October 3.
    1. Kaiser MG1, Eck JC, Groff MW, Ghogawala Z, Watters WC 3rd, Dailey AT et al. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 17: bone growth stimulators as an adjunct for lumbar fusion. J Neurosurg Spine. 2014;21:133–9. 10.3171/2014.4.SPINE14326
    1. Cronkey J, LaPorta G. Rating systems for evaluation of functional ankle instability: prospective evaluation in a cohort of women treated with monopolar capacitive-coupled radiofrequency. Foot Ankle Spec. 2012;5:293–9. 10.1177/1938640012457941
    1. Leeman L, Fullilove AM, Borders N, Manocchio R, Albers LL, Rogers RG. Postpartum perineal pain in a low episiotomy setting: association with severity of genital trauma, labor care, and birth variables.Birth. 2009;36:283–8. 10.1111/j.1523-536X.2009.00355.x
    1. Kahan BC, Jairath V, Doré CJ, Morris TP. The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies. Trials. 2014; 15: 139 10.1186/1745-6215-15-139
    1. Prabhu M, Garry EM, Hernandez-Diaz S, MacDonald SC, Huybrechts KF, Bateman BT. Frequency of Opioid Dispensing After Vaginal Delivery. Obstet Gynecol. 2018;132:459–465. 10.1097/AOG.0000000000002741
    1. .,.
    1. Fatton B, Letouzey V, Lagrange E, Mares P, Jacquetin B, de Tayrac R. Validation of a Frecnh version of the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). J Gynecol Obstet Biol Reprod. 2009. December;38(8):662–7.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅