Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health

NCT06660212 | Recruiting

• 1 other identifier: H-08-24-10662
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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. 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. 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. 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?

Conditions

Vulvodynia; Dyspareunia; Provoked Vestibulodynia

Keywords

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

Outcome Measures

Primary Outcomes (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

  Baseline

• 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

  Within 2 weeks of the end of intervention

• 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

  6 months post start of intervention

• 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

  12 months post start of intervention

Secondary Outcomes (39)

• Tampon Test

  Baseline

• Tampon Test

  Within 2 weeks of the end of the intervention

• Tampon Test

  6 months post start of the intervention

• Tampon Test

  12 months post start of the intervention

• Provoked vulvar pain sensitivity

  Baseline

Study Arms (4)

Sham laser

SHAM COMPARATOR

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.

Device: Sham photobiomodulation

Real laser

ACTIVE COMPARATOR

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.

Device: Photobiomodulation

Sham laser + multi-modal physiotherapy

ACTIVE COMPARATOR

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.

Device: Sham photobiomodulation; Procedure: Multimodal physiotherapy

Laser + multi-modal physiotherapy

EXPERIMENTAL

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.

Device: Photobiomodulation; Procedure: Multimodal physiotherapy

Interventions

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

Also known as: Low level laser therapy

Laser + multi-modal physiotherapy; Real laser

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

Sham laser; Sham laser + multi-modal physiotherapy

Multimodal physiotherapy PROCEDURE

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.

Also known as: Physiotherapy

Laser + multi-modal physiotherapy; Sham laser + multi-modal physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ottawa: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• University of Laval, Quebec City, Canada: collaborator
• BioFlexTM Laser Therapy: collaborator

Study Sites (2)

Motor Function Measurement Lab

Ottawa, Ontario, K1S 1S2, Canada

RECRUITING

Bernard Lab

Québec, Quebec, Canada

RECRUITING

Related Publications (18)

• Dargie E, Holden RR, Pukall CF. The Vulvar Pain Assessment Questionnaire: Factor Structure, Preliminary Norms, Internal Consistency, and Test-Retest Reliability. J Sex Med. 2017 Dec;14(12):1585-1596. doi: 10.1016/j.jsxm.2017.10.072.

  PMID: 29198513 BACKGROUND

• Vowles KE, Kruger ES, Bailey RW, Sowden G, Ashworth J, Hickman J, McCracken LM. Initial evaluation of the Chronic Pain Acceptance Questionnaire - 2. Eur J Pain. 2020 Nov;24(10):2027-2036. doi: 10.1002/ejp.1650. Epub 2020 Sep 21.

  PMID: 32816389 BACKGROUND

• Vandyken C, Hilton S. Physical Therapy in the Treatment of Central Pain Mechanisms for Female Sexual Pain. Sex Med Rev. 2017 Jan;5(1):20-30. doi: 10.1016/j.sxmr.2016.06.004. Epub 2016 Aug 3.

  PMID: 27498209 BACKGROUND

• LePage K, Selk A. What Do Patients Want? A Needs Assessment of Vulvodynia Patients Attending a Vulvar Diseases Clinic. Sex Med. 2016 Dec;4(4):e242-e248. doi: 10.1016/j.esxm.2016.06.003. Epub 2016 Jul 30.

  PMID: 27484917 BACKGROUND

• Bergeron S, Binik YM, Khalife S, Pagidas K, Glazer HI, Meana M, Amsel R. A randomized comparison of group cognitive--behavioral therapy, surface electromyographic biofeedback, and vestibulectomy in the treatment of dyspareunia resulting from vulvar vestibulitis. Pain. 2001 Apr;91(3):297-306. doi: 10.1016/S0304-3959(00)00449-8.

  PMID: 11275387 BACKGROUND

• Lev-Sagie A, Kopitman A, Brzezinski A. Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial. J Sex Med. 2017 Nov;14(11):1403-1411. doi: 10.1016/j.jsxm.2017.09.004. Epub 2017 Sep 29.

  PMID: 28970071 BACKGROUND

• Dargie EE, Chamberlain SM, Pukall CF. Provoked Vestibulodynia: Diagnosis, Self-Reported Pain, and Presentation During Gynaecological Examinations. J Obstet Gynaecol Can. 2017 Mar;39(3):145-151. doi: 10.1016/j.jogc.2017.01.001.

  PMID: 28343555 BACKGROUND

• McLean L, Thibault-Gagnon S, Brooks K, Goldfinger C, Pukall C, Chamberlain S. Differences in Pelvic Morphology Between Women With and Without Provoked Vestibulodynia. J Sex Med. 2016 Jun;13(6):963-71. doi: 10.1016/j.jsxm.2016.04.066.

  PMID: 27215690 BACKGROUND

• Morin M, Bergeron S, Khalife S, Mayrand MH, Binik YM. Morphometry of the pelvic floor muscles in women with and without provoked vestibulodynia using 4D ultrasound. J Sex Med. 2014 Mar;11(3):776-85. doi: 10.1111/jsm.12367. Epub 2013 Nov 6.

  PMID: 24344835 BACKGROUND

• Gentilcore-Saulnier E, McLean L, Goldfinger C, Pukall CF, Chamberlain S. Pelvic floor muscle assessment outcomes in women with and without provoked vestibulodynia and the impact of a physical therapy program. J Sex Med. 2010 Feb;7(2 Pt 2):1003-22. doi: 10.1111/j.1743-6109.2009.01642.x. Epub 2010 Jan 6.

  PMID: 20059663 BACKGROUND

• Reissing ED, Brown C, Lord MJ, Binik YM, Khalife S. Pelvic floor muscle functioning in women with vulvar vestibulitis syndrome. J Psychosom Obstet Gynaecol. 2005 Jun;26(2):107-13. doi: 10.1080/01443610400023106.

  PMID: 16050536 BACKGROUND

• Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.

  PMID: 21951710 BACKGROUND

• Meyer-Bahlburg HF, Dolezal C. The female sexual function index: a methodological critique and suggestions for improvement. J Sex Marital Ther. 2007 May-Jun;33(3):217-24. doi: 10.1080/00926230701267852.

  PMID: 17454519 BACKGROUND

• Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.

  PMID: 10782451 BACKGROUND

• Pukall CF, Young RA, Roberts MJ, Sutton KS, Smith KB. The vulvalgesiometer as a device to measure genital pressure-pain threshold. Physiol Meas. 2007 Dec;28(12):1543-50. doi: 10.1088/0967-3334/28/12/008. Epub 2007 Dec 3.

  PMID: 18057518 BACKGROUND

• Goldstein AT, Pukall CF, Brown C, Bergeron S, Stein A, Kellogg-Spadt S. Vulvodynia: Assessment and Treatment. J Sex Med. 2016 Apr;13(4):572-90. doi: 10.1016/j.jsxm.2016.01.020. Epub 2016 Mar 25.

  PMID: 27045258 BACKGROUND

• Spoelstra SK, Dijkstra JR, van Driel MF, Weijmar Schultz WC. Long-term results of an individualized, multifaceted, and multidisciplinary therapeutic approach to provoked vestibulodynia. J Sex Med. 2011 Feb;8(2):489-96. doi: 10.1111/j.1743-6109.2010.01941.x.

  PMID: 20646179 BACKGROUND

• Harlow BL, Stewart EG. A population-based assessment of chronic unexplained vulvar pain: have we underestimated the prevalence of vulvodynia? J Am Med Womens Assoc (1972). 2003 Spring;58(2):82-8.

  PMID: 12744420 BACKGROUND

MeSH Terms

Conditions

Vulvodynia; Dyspareunia

Interventions

Low-Level Light Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Rehabilitation

Study Officials

• Linda McLean, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

• Stephanie Bernard, PhD

  University of Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda McLean, PhD

CONTACT

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

Regina Ding, PhD

CONTACT

613-562-5800; rding@uottawa.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and investigators in this 2x2 factorial clinical trial will be blinded through a process of random allocation managed by a third-party investigator who is not involved in the direct administration of treatments or outcome assessments. This third-party investigator will use a computerized randomization system to assign participants to one of the four treatment groups.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 2x2 factorial

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 28, 2024
• Study Start: March 17, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for 10 years after the publication of the study results.
• Access Criteria: Planned use of data for systematic review or meta-analysis.

Locations

CA (2)