Photobiomodulation therapy for the treatment of vulvar pain among those with provoked vestibulodynia: a randomized controlled trial
Notice bibliographique
Résumé
BACKGROUND: Provoked vestibulodynia (PVD) is characterized by recurring pain confined to the vulvar vestibule; histological studies show inflammatory mediators and neural proliferation in the vulvar tissues. OBJECTIVE: To determine whether a 15-session photobiomodulation (PBM) intervention is more effective than sham-PBM for reducing vulvar pain. Secondary objectives were to evaluate the effect of the PBM intervention on broader domains of vulvar pain, psychological outcomes, sexual function, perceived improvement and satisfaction, as well as to describe adverse events and adherence. DESIGN: Randomized controlled trial. PARTICIPANTS: Participants with PVD were recruited from the local community. ALLOCATION: Randomized allocation to real- or sham-PBM (1:1) was concealed from participants and all members of the research team until after data analysis was complete. OUTCOMES: Primary outcomes: pressure pain threshold (PPT), pain reported on the tampon test, and vulvar pain sensitivity reported on the Vulvar Pain Assessment Questionnaire (VPAQ). Secondary outcomes: pain-related domains reported on the VPAQ, sexual function, depression, anxiety and stress, pain catastrophizing, central sensitization to pain, Patient Global Perception of Improvement (PGPI), Perceived overall percent improvement (P%I), perceived satisfaction with treatment (%), adherence and adverse events. The primary end point was one week following the last PBM intervention session. INTERVENTION: Fifteen sessions of a real- or sham-PBM intervention were delivered over an 8-week period, progressing through five stages of incremental exposure to light in the red and near-infrared spectra applied to the vulvar vestibule, the perineum, and the sacral region. RESULTS: Thirty participants (16 real-PBM, 14 sham-PBM) enrolled and received their intended intervention; one (sham-PBM) was lost to follow-up. Vulvar pain was reduced more in the real- compared to the sham-PBM group; between group differences were 28.2-112.0 g/cm2 (d = 0.61) for PPT, 0.1-2.5 1(d = 0.60) for pain reported on the tampon test, and 0.1-0.9 (d = 0.87) for pain sensations reported on the VPAQ. Changes in other pain-related domains reported on the VPAQ, psychological outcomes and sexual function were not different between the real- and sham-PBM groups. Adherence to the intervention was nearly 100% among those who completed the study. Most participants in both groups were satisfied or very satisfied with the intervention (real-PBM = 80%; sham-PBM = 64%), with no group differences in satisfaction or perception of improvement. CONCLUSIONS: The PBM intervention resulted in greater reductions in vulvar pain than the sham intervention. However, patients did not perceive that the real-PBM was significantly better than the sham-PBM intervention, and the intervention did not impact psychological outcomes or sexual function. ClinicalTrials.gov Identifier: NCT04234542.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,005 | 0,003 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,003 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,012 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».