Grant: Project Grant

Vulvar pain in the form of provoked vestibulodynia (PVD) affects the quality of life and sexual health of more than one in ten Canadian women. The management of PVD is currently insufficient. Multimodal physiotherapy (mPT) involving education on PVD and on chronic pain physiology, desensitization of the vulva and relaxation of the pelvic floor muscles is recommended by guidelines but currently has only limited evidence. Photobiomodulation (PBM) (laser therapy) may be an effective treatment option for those with PVD. Data from our feasibility study suggest that a comprehensive PBM intervention may result in global improvements as high as 30% with concurrent reductions in pain sensitivity by as much as 56%. These results are very promising. Since they act differently, it is plausible that combining PBM and mPT may produce even greater improvements than either intervention alone, but this has never been tested. We plan to conduct a clinical trial on the effectiveness of 12-week interventions involving PBM, mPT, and PBM combined with mPT relative to sham PBM on immediate and long-term improvements in vulvar pain for those with PVD. Our team is ideally situated to successfully implement this trial and to translate the results to patients, health care providers and the public. We have expertise in vulvar pain pathophysiology and measurement, mPT, PBM, clinical trials, patient engagement and knowledge translation. We have already established all methods to be used in the trial, and our feasibility studies suggest that, relative to a sham PBM intervention, both our PBM intervention and our mPT intervention will be effective. Our feasibility trials have demonstrated that we can meet our recruitment targets, retain those enrolled for the duration of the study, and that side effects and adverse events are very unlikely. The proposed study will provide urgently needed high quality evidence supporting the effective management of pain among those with PVD.