242 - Dry needling to treat provoked vestibulodynia: results of a feasibility and acceptability randomized controlled trial
Bibliographic record
Abstract
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
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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 | 0.012 | 0.014 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.004 | 0.002 |
| Insufficient payload (model declined to judge) | 0.011 | 0.001 |
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".