Recruiting

Biomodulation & RehabilitationBiomodulation and Rehabilitation Interventions to tarGet Pelvic Health

Sponsor:

University of Ottawa

Code:

NCT06660212

Conditions

Vulvodynia

Provoked Vestibulodynia

Dyspareunia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Photobiomodulation

Sham photobiomodulation

Multimodal physiotherapy

Study Details

Brief summary:

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.

Conditions

Vulvodynia

Provoked Vestibulodynia

Dyspareunia

Study ID

NCT06660212

Start date

Mar 17, 2025

Status verified date

Apr, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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
Experiencing signs and symptoms consistent with provoked vestibulodynia alone or provoked vestibulodynia plus vaginismus

Exclusion Criteria:

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham laser

15 treatments will be provided over a 14 week period but at an intensity of 1% output for all sites and at all stages. Each treatment will last approximately 20 minutes. At each visit, the array will be applied to the surface of the perineum (red and infrared light), followed by treatment at specific painful sites using the red light probe.

active comparator: Real laser

15 treatments will be provided over a 14 week period. Each treatment will last approximately 20 minutes and will include the laser array first being applied to the surface of the perineum (red and infrared light) and the focal probe will be applied to painful sites on the perineum. All the stages will involve use of the same array and probe placement, but at each stage the dosage will be increased according to the BioFlex protocol.

active comparator: Sham laser + multi-modal physiotherapy

Over 14 weeks, participants will receive 10 physiotherapy sessions and 15 sham laser sessions, lasting a total of 50 minutes. Laser and physiotherapy treatments will be delivered within the same visit where possible. For the physiotherapy, the therapist will start with education, followed by progressive relaxation exercises and deep breathing. Participants will practice graded pelvic floor muscle (PFM) contractions, manual stretching techniques with external palpation, and gradually progressing to the insertion of one or two fingers into the vagina. Finally, vaginal dilators will be used to stretch the vaginal opening and PFMs. The participant will use relaxation breathing and contraction/relaxation cycles to facilitate insertion, progressing to larger dilators as tolerated. For the sham laser, the same protocol will be followed as described in previous arms.

experimental: Laser + multi-modal physiotherapy

This treatment group will receive a combination therapy (i.e., both laser and physiotherapy), with each session lasting up to 50 minutes over a 14 week period. Laser and physiotherapy treatments will be delivered within the same visit where possible. Laser and physiotherapy protocols will be delivered as described in the previous arms.

Interventions

Photobiomodulation

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

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

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.

Primary outcome measure

Vulvar Pain Assessment Questionnaire - Pain Severity [ Time Frame: Baseline ]
Vulvar Pain Assessment Questionnaire - Pain Severity [ Time Frame: Within 2 weeks of the end of intervention ]
Vulvar Pain Assessment Questionnaire - Pain Severity [ Time Frame: 6 months post start of intervention ]
Vulvar Pain Assessment Questionnaire - Pain Severity [ Time Frame: 12 months post start of intervention ]

Central Contacts and Locations

Central contacts

Linda McLean, PhD

613-562-5800 Linda.Mclean@uottawa.ca

Regina Ding, PhD

613-562-5800 rding@uottawa.ca

Locations

Motor Function Measurement Lab

Recruiting

Ottawa, Ontario, Canada, K1S 1S2

Contacts

Lina McLean, PhD

(613) 562-5800 lmclea2@uottawa.ca

Bernard Lab

Recruiting

Québec, Quebec, Canada

Contacts

Stephanie Bernard, PhD

418 656-2131 stephanie.bernard@fmed.ulaval.ca

More Information

Sponsor

University of Ottawa

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

Provoked vestibulodynia
Intervention
Vulvodynia
Double-blinded
Pelvic floor
laser
Vulvar pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2026-05-05.