A Randomized Prospective Pilot Study Investigating the Feasibility and Effects of High Intensity Laser Therapy for Women with Vulvodynia
Notice bibliographique
Résumé
ABSTRACT Introduction Laser therapy and more specifically, High Intensity Laser Therapy (HILT), is an emerging non-invasive and non-ablative treatment modality, that appears promising for treating provoked vestibulodynia (PVD). However, evidence supporting this treatment remains limited so far as no prospective study has examined the feasibility, acceptability and effects in women with PVD. Objective 1) to evaluate the feasibility and acceptability of HILT in women with PVD and 2) to explore the effects of active and sham HILT on pain intensity during intercourse. Methods Women aged 18-45 years suffering from PVD participated in this randomized pilot study. Women were included if they reported pain at the entry of the vagina during vaginal intercourse (intensity of ≥5 on a numerical rating scale (NRS)) for more than three months. A standardized pelvic examination was performed by a gynecologist from our team to confirm the eligibility of participants. Women were randomized to receive bi-weekly sessions of active (n=20) or sham HILT (n=20) for 6 weeks. Women were assessed at baseline and post-treatment (2 weeks after the end of the treatment). Patients, outcome assessors and data analysts were blinded to group assignation. The attendance rate at laser sessions (≥80% of participants attending ≥10 sessions), the dropout rate (˂15%) and the absence of serious adverse events served as feasibility and acceptability outcomes and benchmarks. Patients’ perceived improvement and satisfaction were also assessed. The effects of treatment on mean pain intensity during intercourse were measured. Results A total of 45 women were screened by the gynecologist and 40 were enrolled in the study (n=5 were excluded because of other diagnoses i.e. infection, dermatological conditions). Among the women included, only one participant in the real HILT group dropped out of the study at post-treatment due to time constraints. Regarding the attendance rate for treatment, the 12 sessions were completed by all participants, except for two women who had 11 sessions due to Covid-related reasons. No serious side effects were observed in either group. In regard to patients’ global impression of change, 79% of women reported significant improvement in the active HILT group as opposed to 47% in the sham group. In the sham group only, 10% reported worsening of their condition. Regarding satisfaction to treatment, women in the active group were more satisfied with a mean of 6.6/10 (SD 2.8) compared to 4.6/10 (SD 3.1) in the sham group (p<0.05). A significant reduction in pain from baseline to post-treatment was found for women in the active HILT group (baseline 7.3±1.3; post-treatment 4.1±2.2; p˂.001) and sham HILT group (baseline 7.4±1.6; post-treatment 5.4±3.2; p=.002). Conclusions HILT is a feasible and acceptable intervention to treat women with PVD. With the significant improvements observed, findings support conducting a randomized controlled trial to confirm the efficacy of this promising intervention. Disclosure No
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 distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,005 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
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 tête enseignante, 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 ».