Biomodulation and Rehabilitation Interventions to TarGet Pelvic Health

NARecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

March 17, 2025

Primary Completion Date

October 31, 2027

Study Completion Date

November 30, 2028

Conditions
VulvodyniaProvoked VestibulodyniaDyspareunia
Interventions
DEVICE

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

DEVICE

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

PROCEDURE

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.

Trial Locations (2)

K1S 1S2

RECRUITING

Motor Function Measurement Lab, Ottawa

Unknown

RECRUITING

Bernard Lab, Québec

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

University of Laval, Quebec City, Canada

UNKNOWN

collaborator

BioFlexTM Laser Therapy

UNKNOWN

lead

University of Ottawa

OTHER