About this trial

This trial will provide evidence for the effective management of pain and pain-related domains among those who experience provoked vestibulodynia (PVD) using photobiomodulation (PBM) and multimodal physiotherapy (mPT) in a randomized controlled trial (RCT). PVD is the most common subcategory of vulvovaginal pain experienced during sexual and non-sexual activities, affects the psychological and sexual health of an astounding one in five Canadian women, yet access to evidence-informed management approaches is limited. We will employ four intervention groups: PBM, sham PBM (control), PBM combined with mPT, and mPT with sham PBM to evaluate the effectiveness of each approach on its own and the two approaches in combination.

Among those who experience PVD, we seek to answer:

1. Relative to baseline and to sham PBM, does a 14-week intervention involving PBM, mPT, or a combination of mPT and PMB reduce vulvar pain severity reported on the Vulvar Pain Assessment Questionnaire (VPAQ)? 2. Is a combined mPT and PBM intervention more effective than mPT or PMB alone when considering vulvar pain severity and/or related domains as measured through VPAQ? 3. Are positive changes in vulvar pain severity and related domains observed following a 14-week intervention involving PBM, mPT or a combination of PBM and mPT retained at 6 months and at 1 year?

Secondary objectives include determining the effectiveness of PBM, mPT, and mPT combined with PBM relative to sham PBM on: Patient Global Impression of Change (PGIC), pain sensitivity measured using provocative tests, the other domains of the VPAQ, sexual function, as well as investigating mediating effects of psychosocial variables (central sensitization index, chronic pain acceptance), gender identity, and the presence of vaginismus on patient response to mPT, PBM and mPT combined with PBM. Lastly we will monitor patient satisfaction with the interventions, adherence to the interventions, and any adverse events.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing to travel to Ottawa area or Quebec City area

Biologically born female older than eighteen years

Pre-menopausal

Not currently pregnant or pregnancy/given birth in the past six months

Disqualifiers

gynaecologist cannot insert a single digit intravaginally and thus the participant would be unlikely able to tolerate the assessment procedures

other gynaecologic conditions such as lichen sclerosus, fissures, endometriosis, adenomyosis, or pelvic organ prolapse

Trial design

Design model

Factorial

Treatments tested in this trial

Photobiomodulation
Device
The laser therapy will be delivered in progressively higher doses, based on individual participants. Each stage will follow this sequence of applications: (1) perineum application (DUO-240 red and infrared array in the surface of the perineum) and (2) LDR-100 probe on the vestibula more generally. Doses will increase from 40%-100% power over the course of the intervention
Sham photobiomodulation
Device
The laser therapy will be delivered in progressively higher doses, based on individual participants tolerance. Each stage will follow this sequence of applications: (1) perineum application (DUO-240 red and infrared array in the surface of the perineum) and (2) LDR-100 probe on the vestibula more generally. . Doses will always be set to 1% power over the course of the intervention
Multimodal physiotherapy
Procedure/Surgery
A total of 10 sessions of multimodal physiotherapy interventions will be provided to each of the participants in the multimodal physiotherapy (mPT) and multimodal physiotherapy combined with photobiomodulation treatment (mPT+PBM) groups. In general, each session will take place in the following order:1) Subjective assessment of the condition and screening for adverse effects or deterioration of the condition, 2)Education, 3) Relaxation Techniques, 4) Pelvic Floor Muscle Exercises, 5) Manual techniques, 6) exercises with accommodators, 7) Global exercises, 8) Assessment of the post-treatment condition and 9) adjustment of the weekly exercise program to be done at home. Each of these 9 treatments will be adjusted and tailored to each participant and progressed based on individual preference and response to treatment under the discretion of the study physiotherapist.

Treatment groups

240 Participants

are divided into 4 treatment groups

Group A: Sham laserSham comparator 1 intervention

Group B: Real laserActive comparator 1 intervention

Group C: Sham laser + multi-modal physiotherapyActive comparator 2 interventions

Group D: Laser + multi-modal physiotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Vulvar Pain Assessment Questionnaire - Pain Severity

Developed by co-investigator Pukall and a subscale of the larger vulvar pain assessment questionnaire, participants report their average and worst vulvar pain intensity and associated unpleasantness and distress experienced during the previous four weeks. Scores are the the average of the items in the subscale, with the lowest possible score as 0 (Not at all) and the highest as 4 (very much). Higher score means worse symptoms

Time frame

Baseline

2

Vulvar Pain Assessment Questionnaire - Pain Severity

Developed by co-investigator Pukall and a subscale of the larger vulvar pain assessment questionnaire, participants report their average and worst vulvar pain intensity and associated unpleasantness and distress experienced during the previous four weeks. Scores are the the average of the items in the subscale, with the lowest possible score as 0 (Not at all) and the highest as 4 (very much). Higher score means worse symptoms

Time frame

Within 2 weeks of the end of intervention

3

Vulvar Pain Assessment Questionnaire - Pain Severity

Developed by co-investigator Pukall and a subscale of the larger vulvar pain assessment questionnaire, participants report their average and worst vulvar pain intensity and associated unpleasantness and distress experienced during the previous four weeks. Scores are the the average of the items in the subscale, with the lowest possible score as 0 (Not at all) and the highest as 4 (very much). Higher score means worse symptoms

Time frame

6 months post start of intervention

4

Vulvar Pain Assessment Questionnaire - Pain Severity

Developed by co-investigator Pukall and a subscale of the larger vulvar pain assessment questionnaire, participants report their average and worst vulvar pain intensity and associated unpleasantness and distress experienced during the previous four weeks. Scores are the the average of the items in the subscale, with the lowest possible score as 0 (Not at all) and the highest as 4 (very much). Higher score means worse symptoms

Time frame

12 months post start of intervention

Secondary outcomes

1

Tampon Test

A proxy measure of intercourse pain. This test involves the participant inserting and removing a non-lubricated regular Tampax tampon, then reporting their overall pain experience using a NRS (0=no pain; 10 = worst possible pain).

Time frame

Baseline

2

Tampon Test

A proxy measure of intercourse pain. This test involves the participant inserting and removing a non-lubricated regular Tampax tampon, then reporting their overall pain experience using a NRS (0=no pain; 10 = worst possible pain).

Time frame

Within 2 weeks of the end of the intervention

3

Tampon Test

A proxy measure of intercourse pain. This test involves the participant inserting and removing a non-lubricated regular Tampax tampon, then reporting their overall pain experience using a NRS (0=no pain; 10 = worst possible pain).

Time frame

6 months post start of the intervention

4

Tampon Test

A proxy measure of intercourse pain. This test involves the participant inserting and removing a non-lubricated regular Tampax tampon, then reporting their overall pain experience using a NRS (0=no pain; 10 = worst possible pain).

Time frame

12 months post start of the intervention

Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

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