Interest of Tecartherapy on a Painful Caesarean Section Scar: a Randomized Clinical Trial. (NOCEPAIN)
Cesarean Section, Postpartum, Abdominal Pain
About this trial
This is an interventional treatment trial for Cesarean Section focused on measuring Maternal morbidity, Pain after a cesarean delivery, Postpartum care, Postnatal care
Eligibility Criteria
Inclusion Criteria: Adult woman(≥18 years and ≤50 years), with a painful cesarean scar (VAS ≥ 4), at the 6-8 weeks postpartum visit (reimbursed by the French national health insurance fund), regardless of whether or not she is breastfeeding, Capable of providing informed consent to participate in this study, and affiliated with the French health insurance fund. Exclusion Criteria: Refusal to participate, Has a pacemaker or a neurostimulator, Has an insulin pump, Coagulation disorders, Current thrombophlebitis, Current pregnancy, Burning sensation at the treatment area, Current cancer, Insensitivity to warm or to pain, Current infection (tuberculosis, etc.), especially of the surgical site, Current fever, Bladder wound during cesarean, Under guardianship or conservatorship, deprived freedom, or in the custody of correctional authorities, Keloid scar from previous cesarean, Previous tecar therapy, Strong hypertension (systolic > 150 or diastolic > 100) or hypotension (systolic ≤90 and diastolic < 40 mm Hg), Dermatologic lesion in the area to be treated (eczema, psoriasis, herpes zoster, etc.), subumbilical midline incision. Chronic inflammatory disease. Under a guardianship or conservatorship, deprived of freedom, or in the custody of correctional authorities.
Sites / Locations
- CHU clermont-ferrandRecruiting
- CH de Vichy
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Interventionnal Group
Control
These women will receive Tecar by Winback® technology [CE medical 1984, Norma 60601-2, ISO9001, ISO13485, CET 400 VA and RET 100 Watts, weight 4 Kg]. Each session will last for 20 minutes, and each individual will have 3 sessions over a period of 3 weeks
The women will follow the same study design as the experimental group with activation of the portable placebo device identical to the active medical . Each session will last for 20 minutes, and each individual will have 3 sessions over a period of 3 weeks.