A sham-controlled randomised trial of Tecar therapy for painful caesarean scars: the NOCEPAIN study protocol
Bibliographic record
Abstract
INTRODUCTION: Caesarean section is a frequent procedure in obstetrics, accounting for 21.4% of deliveries in France in 2021. Three months after delivery, 15.4% of these women report they still have pain, which can be associated with psychological disorders (including anxiety and depression). Although the only treatment currently recommended is self-massage of the scar, capacitive and resistive electric transfer (Tecar) therapy could improve healing and reduce pain associated with caesarean scars and, therefore, improve women's health-related quality of life (QoL). We aim to evaluate the analgesic efficacy of Tecar therapy for postoperative scar pain and/or discomfort at 3 months postpartum by comparing it with sham Tecar therapy. METHODS AND ANALYSIS: The NOCEPAIN study is a two-centre, single-blind, two-arm, parallel-group, sham-controlled randomised trial currently underway. A total of 120 women with a caesarean scar still painful at 6-8 weeks postpartum, aged 18-50 years, are being randomly allocated in a ratio of 1:1 to either the active Tecar therapy group (active device group) or the sham Tecar therapy group (placebo device group). The women undergo one Tecar or sham session of 20 min per week for 3 weeks. Women in both groups also receive the recommended standard treatment: manual self-massage of the scar.The primary outcome is the caesarean scar pain and/or discomfort at 3 months postpartum, assessed with a Visual Analogue Scale from 0 (no pain and/or discomfort) to 10 (the worst imaginable). Secondary outcomes include validated self-report questionnaires about pain (French adaptations of the McGill Pain Questionnaire and the Brief Pain Inventory, as well as the 'Douleur Neuropathique en 4 Questions' instrument for neuropathic pain), the interference of pain with activities of daily living (Multidimensional Pain Inventory), anxiety and depression (Hospital Anxiety and Depression Scale), health-related QoL (WHO QoL Brief) and sexual functioning (Female Sexual Function Index). The final secondary outcomes are the quality of skin healing (Vancouver Scar Scale), as well as analgesic use and concomitant treatments for analgesia. ETHICS AND DISSEMINATION: The West III Committee for the Protection of Persons (French Institutional Review Board) approved this study and its compliance with French individual data protection laws (number: 2022-A01492-41, 20 March 2023). All participants provide written informed consent before randomisation. The results will be reported in peer-reviewed journals and at scientific meetings. TRIAL REGISTRATION NUMBER: NCT05696301.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.007 |
| Meta-epidemiology (narrow) | 0.005 | 0.002 |
| Meta-epidemiology (broad) | 0.008 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.005 | 0.004 |
| Insufficient payload (model declined to judge) | 0.035 | 0.005 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".