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

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 a...

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Bibliographic Details
Published in:American journal of obstetrics and gynecology 2021-02, Vol.224 (2), p.189.e1-189.e12
Main Authors: Morin, Mélanie, Dumoulin, Chantale, Bergeron, Sophie, Mayrand, Marie-Hélène, Khalifé, Samir, Waddell, Guy, Dubois, Marie-France, Girard, Isabelle, Bureau, Yves-André, Ouellet, Stéphane, Reichetzer, Barbara, Simard-Émond, Laurence, Brochu, Ian
Format: Article
Language:English
Subjects:
Administration, Topical
Adult
Anesthetics, Local - therapeutic use
biofeedback
Biofeedback, Psychology - methods
chronic pelvic pain
Coitus
Dilatation - methods
Female
Humans
Lidocaine - therapeutic use
manual therapy
Muscle Stretching Exercises
Musculoskeletal Manipulations - methods
pain education
Patient Satisfaction
Pelvic Floor
Physical Therapy Modalities
physiotherapy
Psychological Distress
randomized clinical trial
rehabilitation
sexual dysfunction
Sexual Dysfunction, Physiological - physiopathology
Sexual Dysfunction, Physiological - psychology
Sexual Dysfunctions, Psychological - physiopathology
Sexual Dysfunctions, Psychological - psychology
vulvodynia
Vulvodynia - physiopathology
Vulvodynia - psychology
Vulvodynia - therapy
women’s health
Young Adult
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Summary: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. The purpose of this study was to establish the efficacy of multimodal physical therapy compared with topical lidocaine, a frequently used first-line treatment. 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. 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
ISSN:0002-9378
1097-6868
DOI:10.1016/j.ajog.2020.08.038