242 - Dry needling to treat provoked vestibulodynia: results of a feasibility and acceptability randomized controlled trial
Notice bibliographique
Résumé
Hypothesis / aims of study Provoked vestibulodynia (PVD), the most common subtype of vulvodynia, is characterized by chronic sharp pain at the vaginal entry upon pressure or attempted penetration. Despite the high prevalence of this condition, patients face a scarcity of effective therapeutic options [1] . Dry needling (DN) has shown promising results in treating various musculoskeletal conditions by targeting abnormally increased muscle tone, a key factor in the pathophysiology of PVD [2] . However, this treatment approach has never been examined for the treatment of PVD. This study aimed to 1) assess the feasibility and acceptability of using DN to treat women with PVD, and 2) explore the effects of realDN compared to shamDN on pain intensity. Study design, materials and methods A parallel, 2-group, randomized feasibility and acceptability study was conducted. The design and methodology complied with the recommendations of the CONSORT extension for feasibility trials. Forty-six women aged 18 to 45 years old and diagnosed with PVD by a gynecologist on our team were randomly assigned (1:1) to receive either weekly sessions of realDN or shamDN for six weeks. Feasibility was measured throughout the study and included adherence to treatments, completion of questionnaires, retention rates and side effects. Acceptability was assessed at posttreatment with a validated questionnaire. Pain intensity during intercourse (numerical rating scale 0-10) was measured at baseline and posttreatment. The sample size of 46 participants was calculated a priori based on adherence (>70%) and retention (>85%) rates, using a one-sample, two-sided test with a 5% alpha level, 80% power, and a 10% anticipated dropout rate [3] . Linear mixed model, following an intention-to-treat approach, was used to examine the effects of DN on pain. Results Women in the realDN group attended 99% of the scheduled treatment sessions, compared to 91% in the shamDN group (p >.05). Additionally, 100% of the questionnaires were completed in the realDN group, compared to 93% in the shamDN group (p >.05). All participants in the realDN group completed the study, whereas two participants in the shamDN group withdrew. Regarding the main side effects, 96% of the participants in the realDN group and 52% in the shamDN group experienced muscle aches (p < .001). Moreover, 35% experienced autonomic reactions (sweating, nausea, tremors, fatigue) in the realDN group, while no such reactions were observed in the shamDN group (p < .001). All participants reported high levels of acceptability, with no significant difference between groups (p >.05). Women in the realDN group showed a greater reduction in pain than those in the shamDN group, with a mean difference at posttreatment of 2.4 [95%CI 1.4; 3.3] (p < .001). Interpretation of results This study was the first to examine the feasibility, acceptability and effects of DN for treating PVD. The high adherence rates to treatment and questionnaire completion, along with a very low dropout rate, surpassed our predetermined feasibility benchmarks. The overall perception of the acceptability of DN was high in both groups. These findings support the feasibility and acceptability of using DN to treat women suffering from PVD. In accordance with the literature, no major side effects occurred. This study demonstrated that realDN resulted in a statistically significant and clinically meaningful greater reduction in pain intensity during intercourse compared to shamDN. Concluding message This study's findings support DN's feasibility and acceptability in treating women with PVD. They also demonstrated a clinically and statistically significant effect on pain. The results lay the groundwork for a larger randomized controlled trial needed to establish the efficacy of DN in that population. Funding This work was supported by the Partenariat de recherche clinique en physiothérapie of the OPPQ/ REPAR and the National Women's Health Research Initiative of the Canadian Institutes of Health Research. Melanie Roch received a doctoral scholarship and Melanie Morin, a salary award from Fonds de Recherche en Santé du Québec. Clinical Trial Yes Registration Number ClinicalTrials.gov, NCT05797480 RCT Yes Subjects Human Ethics Committee This study was approved by the Human Ethics Committee of CIUSSS de l’Estrie-CHUS approval #2023-4686. Helsinki Yes Informed Consent Yes
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 | 0,012 | 0,014 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,006 | 0,003 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,002 |
| Communication savante | 0,002 | 0,002 |
| Science ouverte | 0,002 | 0,001 |
| Intégrité de la recherche | 0,004 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,011 | 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 ».