Multimodal physical therapy versus topical lidocaine for provoked vestibulodynia: a multicenter, randomized trial

Abstract

Background: Provoked vestibulodynia is the most common subtype of chronic vulvar pain. This highly prevalent and debilitating condition is characterized by acute recurrent pain located at the entry of the vagina in response to pressure application or attempted vaginal penetration. Although physical therapy is advocated as a first-line treatment for provoked vestibulodynia, evidence supporting its efficacy is scarce.

Objective: The purpose of this study was to establish the efficacy of multimodal physical therapy compared with topical lidocaine, a frequently used first-line treatment.

Study design: We conducted a multicenter, parallel-group, randomized clinical trial in women diagnosed as having provoked vestibulodynia recruited from the community and 4 Canadian university hospitals. Women were randomly assigned (1:1) to receive either weekly sessions of physical therapy or overnight topical lidocaine (5% ointment) for 10 weeks. Randomization was stratified by center using random permuted blocks from a computer-generated list managed by an independent individual. Physical therapy entailed education, pelvic floor muscle exercises with biofeedback, manual therapy, and dilation. Assessments were conducted at baseline, posttreatment, and 6-month follow-up. Outcome assessors, investigators, and data analysts were masked to allocation. The primary outcome was pain intensity during intercourse evaluated with the numeric rating scale (0-10). Secondary outcomes included pain quality (McGill-Melzack Pain Questionnaire), sexual function (Female Sexual Function Index), sexual distress (Female Sexual Distress Scale), satisfaction (numeric rating scale of 0-10), and participants' impression of change (Patient Global Impression of Change). Intention-to-treat analyses were conducted using piecewise linear-growth models.

Results: Among 212 women who were recruited and randomized, 201 (95%) completed the posttreatment assessment and 195 (92%) completed the 6-month follow-up. Multimodal physical therapy was more effective than lidocaine for reducing pain intensity during intercourse (between-group pre-post slope difference, P<.001; mean group postdifference, 1.8; 95% confidence interval, 1.2-2.3), and results were maintained at 6-month follow-up (mean group difference, 1.8; 95% confidence interval, 1.2-2.5). The physical therapy group also performed better than the lidocaine group in all secondary outcomes (pain quality, sexual function, sexual distress, satisfaction, and participants' impression of change) at posttreatment and 6-month follow-up. Moreover, the changes observed after physical therapy were shown to be clinically meaningful. Regarding participants' impression of change, 79% of women in the physical therapy group reported being very much or much improved compared with 39% in the lidocaine group (P<.001).

Conclusion: The findings provide strong evidence that physical therapy is effective for pain, sexual function, and sexual distress and support its recommendation as the first-line treatment of choice for provoked vestibulodynia.

Trial registration: ClinicalTrials.gov NCT01455350.

Keywords: biofeedback; chronic pelvic pain; manual therapy; pain education; pelvic floor; physiotherapy; psychological distress; randomized clinical trial; rehabilitation; sexual dysfunction; vulvodynia; women’s health.