Using Tecartherapy to Treat Painful Cesarean Section Scars
Interest of Tecartherapy on a Painful Caesarean Section Scar: a Randomized Clinical Trial.
This study is testing if tecar therapy can help women with painful cesarean section scars feel better three months after giving birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 2 sites (Clermont-Ferrand and 1 other locations) |
| Trial ID | NCT05696301 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of tecar therapy in alleviating pain associated with cesarean section scars. It involves a randomized, single-blind design with two parallel groups: one receiving active tecar therapy and the other receiving sham treatment, alongside standard self-massage techniques. The primary goal is to assess pain relief at three months postpartum in women experiencing significant discomfort from their surgical scars. Participants will be recruited during their routine postnatal consultations.
Who should consider this trial
Good fit: Ideal candidates are adult women aged 18 to 50 with a painful cesarean scar rated at 4 or higher on the Visual Analog Scale, attending their postpartum visit.
Not a fit: Patients with contraindications such as pacemakers, current infections, or those who have had previous tecar therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce postoperative pain and improve the quality of life for women recovering from cesarean deliveries.
How similar studies have performed: While tecar therapy is a relatively novel approach for this specific application, similar modalities have shown promise in managing pain in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Clermont-Ferrand and 1 other locations
- CHU clermont-ferrand — Clermont-Ferrand, France (Recruiting)
- CH de Vichy — Vichy, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Françoise Vendittelli — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.