Cesarean SectionNOCEPAINNCT05696301
Interest of Tecartherapy on a Painful Caesarean Section Scar: a Randomized Clinical Trial.
A study testing Winback® on, Winback® off and self-massage of the scar in people with Cesarean Section and Postpartum, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cesarean Section, Postpartum, Abdominal Pain
- What is being tested?
- Winback® on, Winback® off and self-massage of the scar
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jul 2023to 19 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Refusal to participate,
- Has a pacemaker or a neurostimulator,
- Has an insulin pump,
- Coagulation disorders,
- Current thrombophlebitis,
- Current pregnancy,
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
- Study design: A randomized clinical trial with 2 parallel arms and single blinding to study the efficacy of this medical device for therapeutic purposes.
- Procedure for early withdrawal from the treatment:
A woman can withdraw from the study early for the following reasons:
- intercurrent disease interfering with the study organization and normal protocol procedures (i.e., prolonged hospitalization for a disorder other than gynecologic or obstetric),
- death,
- the woman's decision,
- a major protocol deviation,
- and loss to follow-up (a subject lost to follow-up is a participant who did not come to the visit planned in the protocol and for whom we lack information on which we could base a judgment. It is essential to attempt by all reasonable means to obtain information and learn the reason why these women withdrew from the trial. "Lost to follow-up" will be invoked only when the investigation has been unsuccessful).
The trial may be stopped temporarily or permanently for the following reasons:
- Recruitment too low or nonexistent,
- Impossibility of obtaining funding for the trial,
- Any directive by competent authorities requiring the temporary or permanent end of the trial,
- Decision of the sponsor and of the investigator-coordinator.
- Methods of recruitment Physician, in both obstetrics departments in which the study is planned will inform the women of the study during their postnatal consultation, planned by statute in France at 6 to 8 weeks after delivery. They will also be informed by posters displayed in the consultation sector of the two obstetrics departments.
If they are willing, they will be offered the opportunity to participate in the study; if so, a telephone appointment will be arranged for re-verification of their eligibility criteria by the research midwives at the academic hospital of Estaing or the clinical research assistants at the Vichy Hospital Center. If she is indeed eligible for the study, an inclusion visit will be scheduled. At this visit, the investigator-physician will verify the file with the woman (review her history) and examine the woman (blood pressure and examination of the skin of and around the scar). She will also receive a more detailed note of information. After a conversation with the investigator, who will answer her questions, the woman can sign the consent form. The investigator will also sign the consent form. The women will receive structured training on how to massage the scar (and also a paper information about the massage of the scar) and their first session of treatment by tecar therapy (or sham tecar therapy) at the end of this inclusion visit.
On average, the time to reflect between the first oral information about the study and the written consent signature will be one week.
- Conditions
- Cesarean Section, Postpartum, Abdominal Pain, Morbidity
- Being tested
- Winback® on, Winback® off, self-massage of the scar
- Keywords
- Maternal morbidity, Pain after a cesarean delivery, Postpartum care, Postnatal care
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Winback® onDevice
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.
Winback® offDevice
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.
self-massage of the scarBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Winback® off; Behavioral: self-massage of the scar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Pain and/or discomfort will be evaluated by a VAS, with a ruler scored from 0 for no pain to 10 for the worst imaginable.
Measured: Week 3
Pain and/or discomfort due to cesarean scar at 6 months post partum
Pain and/or discomfort will be evaluated by a VAS, with a ruler scored from 0 for no pain to 10 for the worst imaginable.
Measured: Month 6
Pain due to cesarean scar in the early postpartum period
Saint Antoine self-administered pain questionnaire, abridged version (QDSA, French adaptation of the McGill Pain questionnaire): at the end of the tecar therapy sessions
Measured: Week 3
Pain due to cesarean scar in the early postpartum period
Saint Antoine self-administered pain questionnaire, abridged version (QDSA, French adaptation of the McGill Pain questionnaire): at the end of the tecar therapy sessions
Measured: Month 3
Pain due to cesarean scar in the early postpartum period
Saint Antoine self-administered pain questionnaire, abridged version (QDSA, French adaptation of the McGill Pain questionnaire): at the end of the tecar therapy sessions
Measured: Month 6
Pain due to cesarean scar in the early postpartum period
Self-administered brief pain questionnaire (QCD, French version of the "Brief Pain Inventory")
Measured: Week 3
Pain due to cesarean scar in the early postpartum period
Self-administered brief pain questionnaire (QCD, French version of the "Brief Pain Inventory")
Measured: Month 3
Pain due to cesarean scar in the early postpartum period
Self-administered brief pain questionnaire (QCD, French version of the "Brief Pain Inventory")
Measured: Month 6
Research for neuropathic pain
Self-administered questionnaire to search for neuropathic pain [DN4]
Measured: Month 3
Research for neuropathic pain
Self-administered questionnaire to search for neuropathic pain [DN4]
Measured: Month 6
Interference with daily activities
Self-administered questionnaire "Multidimensional Pain Inventory" (MPI)
Measured: Week 3
Interference with daily activities
Self-administered questionnaire "Multidimensional Pain Inventory" (MPI)
Measured: Month 3
Interference with daily activities
Self-administered questionnaire "Multidimensional Pain Inventory" (MPI)
Measured: Month 6
Anxiety and depression
Self-administered questionnaire "Hospital Anxiety and Depression Scale" (HADS)
Measured: Month 3
Anxiety and depression
Self-administered questionnaire "Hospital Anxiety and Depression Scale" (HADS)
Measured: Month 6
Health-related quality of life
self-administered questionnaire WHOQOL-BRIEF [WHO questionnaire on Quality of Life]
Measured: Month 3
Health-related quality of life
self-administered questionnaire WHOQOL-BRIEF [WHO questionnaire on Quality of Life]
Measured: Month 6
Quality of sexual life
Self-administered questionnaire "Female Sexual Function Index" [FSFI]
Measured: Month 3
Quality of sexual life
Self-administered questionnaire "Female Sexual Function Index" [FSFI]
Measured: Month 6
Quality of skin healing
Vancouver Scale
Measured: Week 3
Consumption of analgesics or other co-treatments for analgesic purposes
consumption of analgesics and co-treatments collected prospectively during follow-up to allow the economic analysis
Measured: During the 3 months of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start4 Jul 2023
- Primary completion19 Sep 2025
- Study completion19 Sep 2025
Why it stopped: Our low recruitment is related to the fact that few women are in pain in our department 6 to 8 weeks postpartum. It was therefore decided not to extend this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Françoise Vendittelli, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696301
- Sponsor's protocol ID
- AOI 2021 VENDITTELLI
- Other IDs
- 2022-A01492-41
- Acronym
- NOCEPAIN
- Status last verified
- Aug 2025
- First submitted
- 12 Jan 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results generated by this research will be made available as soon as possible in an article. However, the individual data underlying the findings cannot be made freely available because of French legal restrictions. French Data Protection Agency (Commission Nationale de l'Informatique et des Libertés) accordingly strictly forbids making these data freely available. Nonetheless, aggregated anonymous data of the trial can be obtained upon request. Readers will be able to contact the corresponding author to request the data.
Publications
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.
PubMed 41057173
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Tecartherapy on a Painful Caesarean Section Scar: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05696301
- Acronym / sponsor ID
- NOCEPAIN / AOI 2021 VENDITTELLI
- Conditions
- Cesarean Section, Postpartum, Abdominal Pain, Morbidity
- Keywords
- Maternal morbidity, Pain after a cesarean delivery, Postpartum care, Postnatal care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Our low recruitment is related to the fact that few women are in pain in our department 6 to 8 weeks postpartum. It was therefore decided not to extend this study.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Study design: A randomized clinical trial with 2 parallel arms and single blinding to study the efficacy of this medical device for therapeutic purposes.
- Procedure for early withdrawal from the treatment:
A woman can withdraw from the study early for the following reasons:
- intercurrent disease interfering with the study organization and normal protocol procedures (i.e., prolonged hospitalization for a disorder other than gynecologic or obstetric),
- death,
- the woman's decision,
- a major protocol deviation,
- and loss to follow-up (a subject lost to follow-up is a participant who did not come to the visit planned in the protocol and for whom we lack information on which we could base a judgment. It is essential to attempt by all reasonable means to obtain information and learn the reason why these women withdrew from the trial. "Lost to follow-up" will be invoked only when the investigation has been unsuccessful).
The trial may be stopped temporarily or permanently for the following reasons:
- Recruitment too low or nonexistent,
- Impossibility of obtaining funding for the trial,
- Any directive by competent authorities requiring the temporary or permanent end of the trial,
- Decision of the sponsor and of the investigator-coordinator.
- Methods of recruitment Physician, in both obstetrics departments in which the study is planned will inform the women of the study during their postnatal consultation, planned by statute in France at 6 to 8 weeks after delivery. They will also be informed by posters displayed in the consultation sector of the two obstetrics departments.
If they are willing, they will be offered the opportunity to participate in the study; if so, a telephone appointment will be arranged for re-verification of their eligibility criteria by the research midwives at the academic hospital of Estaing or the clinical research assistants at the Vichy Hospital Center. If she is indeed eligible for the study, an inclusion visit will be scheduled. At this visit, the investigator-physician will verify the file with the woman (review her history) and examine the woman (blood pressure and examination of the skin of and around the scar). She will also receive a more detailed note of information. After a conversation with the investigator, who will answer her questions, the woman can sign the consent form. The investigator will also sign the consent form. The women will receive structured training on how to massage the scar (and also a paper information about the massage of the scar) and their first session of treatment by tecar therapy (or sham tecar therapy) at the end of this inclusion visit.
On average, the time to reflect between the first oral information about the study and the written consent signature will be one week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventionnal Group | Experimental | Device: Winback® on, Behavioral: self-massage of the scarThese 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 |
| Control | Sham comparator | Device: Winback® off, Behavioral: self-massage of the scarThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (20 listed)
- Refusal to participate,
- Has a pacemaker or a neurostimulator,
- Has an insulin pump,
- Coagulation disorders,
- Current thrombophlebitis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Winback® onFor 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. | Device | Interventionnal Group |
| Winback® offFor 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. | Device | Control |
| self-massage of the scarThe 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. | Behavioural | Control, Interventionnal Group |
Primary outcome
Analgesic efficacy of tecar therapy on postoperative scar pain and/or discomfort
Time frame: At 3 months after the cesarean delivery
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.
21 secondary outcomes
Pain and/or discomfort for cesarean scars at the end of all 3 sessions of tecar therapy
Time frame: Week 3
Pain and/or discomfort due to cesarean scar at 6 months post partum
Time frame: Month 6
Pain due to cesarean scar in the early postpartum period
Time frame: Week 3
Pain due to cesarean scar in the early postpartum period
Time frame: Month 3
Pain due to cesarean scar in the early postpartum period
Time frame: Month 6
Pain due to cesarean scar in the early postpartum period
Time frame: Week 3
Pain due to cesarean scar in the early postpartum period
Time frame: Month 3
Pain due to cesarean scar in the early postpartum period
Time frame: Month 6
Research for neuropathic pain
Time frame: Month 3
Research for neuropathic pain
Time frame: Month 6
Interference with daily activities
Time frame: Week 3
Interference with daily activities
Time frame: Month 3
Interference with daily activities
Time frame: Month 6
Anxiety and depression
Time frame: Month 3
Anxiety and depression
Time frame: Month 6
Health-related quality of life
Time frame: Month 3
Health-related quality of life
Time frame: Month 6
Quality of sexual life
Time frame: Month 3
Quality of sexual life
Time frame: Month 6
Quality of skin healing
Time frame: Week 3
Consumption of analgesics or other co-treatments for analgesic purposes
Time frame: During the 3 months of follow-up.
Results and safety
The study was stopped early (reason given: Our low recruitment is related to the fact that few women are in pain in our department 6 to 8 weeks postpartum. It was therefore decided not to extend this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Derived from this study: PubMed 41057173Grampayre 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.
- Individual participant dataSharing planned: No. The results generated by this research will be made available as soon as possible in an article. However, the individual data underlying the findings cannot be made freely available because of French legal restrictions. French Data Protection Agency (Commission Nationale de l'Informatique et des Libertés) accordingly strictly forbids making these data freely available. Nonetheless, aggregated anonymous data of the trial can be obtained upon request. Readers will be able to contact the corresponding author to request the data.
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Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Françoise Vendittelli principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Winback® on, Winback® off and self-massage of the scar in people with Cesarean Section and Postpartum, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Our low recruitment is related to the fact that few women are in pain in our department 6 to 8 weeks postpartum. It was therefore decided not to extend this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic efficacy of tecar therapy on postoperative scar pain and/or discomfort (time frame: At 3 months after the cesarean delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05696301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.