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.