Interest of Tecartherapy on a Painful Caesarean Section Scar: a Randomized Clinical Trial.

NCT05696301 | Terminated

• 2 other identifiers: AOI 2021 VENDITTELLI2022-A01492-41
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Cesareans are a frequent procedure in obstetrics and 15.4% (95% CI, 9.9-20.9%) of women with cesareans still have pain at 3 months after delivery. Currently, self-massage of the scar is recommended to them. Post-cesarean pain is associated with psychological disorders (including, e.g., anxiety, depression). Tecar therapy could improve the healing and pain associated with cesareans and therefore improve women's quality of life and their satisfaction. Objectives: The principal objective is to study the analgesic efficacy of tecar therapy for postoperative scar pain and/or discomfort at 3 month after cesarean delivery, by comparing it with sham tecar therapy. A randomized clinical trial with 2 parallel arms and single blinding, to study the efficacy of this medical device for therapeutic purposes. In both groups (randomization stratified as a first cesarean or repeat cesarean), the women will have the standard recommended treatment - manual self-massage of the scar. Women's instruction in this self-massage will be structured and identical for both groups, including the provision of an informational document describing how to perform this massage. The training will be provided immediately after randomization.

• Description of the experimental group These women will receive Tecar through Winback® technology \[CE medical 1984, Norma 60601-2, ISO9001, ISO13485. Class IIa medical device, CET (capacitative mode) 400 VA and RET (resistant mode) 100 Watts, weight 4 Kg)\]. Each session will last for 20 minutes, and each individual will have 3 sessions over a period of 3 weeks.
• Description of the control group ("sham treatment") 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 3-week period. Principal endpoint: Visual analogic scale (VAS) for pain and/or discomfort at 3 months after delivery partum (with a ruler scored from 0 for no pain to 10 for the worst pain imaginable). Succinct description of the products: "Tecar" is an acronym for a type of therapy (transfer electrical capacitive and resistive). The Winback® is a portable, easy-to-handle noninvasive regenerator. This study will use only the instrumental mode and 4-cm electrodes. During each session, this electrode will be moved over the entire scar. We will use the following 3 modes: capacitive (CET), CET Dynamic, and resistant (RET). These allow us to standardize the treatment without taking into account either the thickness of the abdominal wall or the woman's morphology. Each session will take 20 minutes (CET for 4 min, CET Dynamic 6 min, RET 6 min and CET 4 min). The intensity of CET and RET will be adapted to each woman and the diathermy chosen according to the woman's threshold of comfort, to be determined by her at each session, in the experimental group. There will be 1 session a week for 3 weeks. Study plan and procedures: The eligible women will be identified by the physicians in both of the obstetrics departments participating in this study. The women will receive oral information as well as written information. If they are interested, they will be offered an inclusion visit, normally scheduled for one week later. After a second verification of the eligibility criteria at this inclusion meeting, reading the information form and signing the consent, they will be randomized into one of the two groups by random drawing. Each woman will have 3 sessions (1 session a week for 20 min for 3 consecutive weeks): active treatment by tecar therapy or sham/placebo tecar therapy. They will receive self-administered questionnaires at 3 and 6 months after delivery to be completed and returned.

Conditions

Cesarean Section; Postpartum; Abdominal Pain; Morbidity

Keywords

Maternal morbidity; Pain after a cesarean delivery; Postpartum care; Postnatal care

Outcome Measures

Primary Outcomes (1)

• Analgesic efficacy of tecar therapy on postoperative scar pain and/or discomfort

  To study the analgesic efficacy of tecar therapy on postoperative scar pain and/or discomfort after cesarean delivery. Pain will be evaluated by a visual analogic scale (VAS) at 3 months post partum, by a ruler scored from 0 for no pain and/or discomfort to 10 for the worst imaginable.

  At 3 months after the cesarean delivery

Secondary Outcomes (21)

• Pain and/or discomfort for cesarean scars at the end of all 3 sessions of tecar therapy

  Week 3

• Pain and/or discomfort due to cesarean scar at 6 months post partum

  Month 6

• Pain due to cesarean scar in the early postpartum period

  Week 3

• Pain due to cesarean scar in the early postpartum period

  Month 3

• Pain due to cesarean scar in the early postpartum period

  Month 6

Study Arms (2)

Interventionnal Group

EXPERIMENTAL

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

Device: Winback® on; Behavioral: self-massage of the scar

Control

SHAM COMPARATOR

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.

Device: Winback® off; Behavioral: self-massage of the scar

Interventions

Winback® on DEVICE

For this study, we will use only the instrumental mode and the 4-cm electrodes. During each session, this electrode will be moved over the entire scar, with the contact between electrode and the skin provided by an adequate quantity of conductive cream. We will use the following 3 modes: CET, CET Dynamic, and RET; these allow us to standardize the treatment without taking into account either the thickness of the abdominal wall or the woman's morphology. Each session will take 20 minutes (CET for 4 min, CET Dynamic 6 min, RET 6 min and CET 4 min). The intensity of CET and RET will be adapted to each woman and the diathermy chosen according to the woman's threshold of comfort, to be determined by her at each session. There will be 1 session a week for 3 weeks. Portable instrument is activated.

Interventionnal Group

Winback® off DEVICE

For this study, we will use only the instrumental mode and the 4-cm electrodes. During each session, this electrode will be moved over the entire scar, with the contact between electrode and the skin provided by an adequate quantity of conductive cream. We will use the following 3 modes: CET, CET Dynamic, and RET; these allow us to standardize the treatment without taking into account either the thickness of the abdominal wall or the woman's morphology. Each session will take 20 minutes (CET for 4 min, CET Dynamic 6 min, RET 6 min and CET 4 min). The intensity of CET and RET will be adapted to each woman and the diathermy chosen according to the woman's threshold of comfort, to be determined by her at each session. There will be 1 session a week for 3 weeks. Portable instrument is not activated.

Control

self-massage of the scar BEHAVIORAL

The women in both groups will have the standard recommended treatment: manual self-massage of the scar. Women's instruction in this self-massage will be structured and identical for both groups, including the provision of an informational document describing how to perform the massage. This training will be provided immediately after randomization and before the intervention or control measures.

Control; Interventionnal Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

Location

Related Publications (1)

• Grampayre M, Guiguet-Auclair C, Barasinski C, Vendittelli F. A sham-controlled randomised trial of Tecar therapy for painful caesarean scars: the NOCEPAIN study protocol. BMJ Open. 2025 Oct 6;15(10):e105743. doi: 10.1136/bmjopen-2025-105743.

  PMID: 41057173 DERIVED

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Françoise Vendittelli

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 25, 2023
• Study Start: July 4, 2023
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)